Ohio Adm.Code 4729:5 | Ohio Administrative Code 4729:5 — State Board of Pharmacy | Terminal Distributors of Dangerous Drugs

Chapter 4729:5-1 Definition of Dangerous Drugs

Ohio Adm.Code 4729:5-1-01 Definitions - terminal distributors of dangerous drugs.

As used in this division:

(A) "Terminal distributor of dangerous drugs" or "terminal distributor" means a person who is engaged in the sale of dangerous drugs at retail, or any person, other than a manufacturer, repackager, outsourcing facility, third-party logistics provider, wholesale distributor, or pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person's own use and consumption.

(1) A terminal distributor of dangerous drugs includes pharmacies, hospitals, nursing homes, and laboratories and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist, licensed health professional authorized to prescribe drugs or any other person authorized by the board of pharmacy.

(2) A terminal distributor shall comply with the provisions set forth in this division.

(B) "Abandoned application" means an application submitted for licensure that meets the criteria set forth in paragraph (B)(1) of this rule. An applicant forfeits all fees associated with an abandoned application. The board shall not be required to act on any abandoned application and the application may be destroyed by board staff. If the application is abandoned, the applicant shall be required to reapply for licensure, submit the required fee, and comply with the licensure requirements in effect at the time of reapplication.

(1) An application shall be deemed abandoned if any of the following apply:

(a) An applicant fails to complete all application requirements within thirty days after being notified of the incomplete application by the board.

(b) An applicant for a terminal distributor of dangerous drugs that fails to demonstrate compliance with rule 4729:5-2-01 of the Administrative Code. The applicant may submit a request to the executive director or the director's designee for a one-time, ninety-day extension.

(c) An applicant for a terminal distributor of dangerous drugs that fails to demonstrate compliance with appropriate security and control rules pursuant to this division of the Administrative Code. The applicant may submit a request to the executive director or the director's designee for a one-time, ninety-day extension.

(2) An application shall not be deemed abandoned if the application is subject to any of the following:

(a) An administrative proceeding; or

(b) If there is discipline pending against the applicant.

(C) "Access to drug stock" includes not only physical access, but also any influence over the handling of dangerous drugs such as purchases, inventories, issuance of medical orders, etc. It does not include employees or contractors such as maintenance, janitorial, IT or other staff that may need limited supervised access to areas where dangerous drugs or D.E.A. controlled substance order forms are kept.

(D) "Addicted to or abusing alcohol or drugs" means the chronic and habitual use of alcohol or the use of a drug of abuse as defined in section 3719.011 of the Revised Code by an individual to the extent that the individual no longer can control the individual's use of alcohol or drugs, the individual is physically or psychologically dependent on alcohol or drugs, or the individual's use or abuse of alcohol or drugs endangers the health, safety, or welfare of the individual or others.

(E) "Adulterated drug" includes a dangerous drug to which any of the following applies:

(1) A compounded dangerous drug if it exceeds the assigned beyond-use date.

(2) Meets any of the requirements described in section 3715.63 of the Revised Code.

(3) Is beyond the expiration date as stated by the manufacturer, repackager, or distributor in its labeling. This does not apply to expired drugs that are donated pursuant to sections 3715.88 to 3715.92 of the Revised Code.

(4) Is not stored, dispensed or personally furnished according to the requirement of the federal act as indicated in the product labeling.

(F) "Board of pharmacy" or "board" means the state board of pharmacy established under Chapter 4729. of the Revised Code.

(G) "Business day" means any day other than Saturday, Sunday or a holiday recognized by the state of Ohio on which the offices of the board of pharmacy are not open for business.

(H) "Campus," as used to describe a type of terminal distributor of dangerous drugs license issued pursuant to section 4729.54 of the Revised Code, means an establishment or place consisting of multiple buildings where dangerous drugs are stored that are located on a contiguous plot of land. All such buildings and stocks of dangerous drugs shall be under common ownership and control.

(I) "Certified diabetes educator," as used in Chapters 3719. and 4729. of the Revised Code, means a person who has been certified to conduct diabetes education by the "National Certification Board for Diabetes Educators" (NCBDE).

(J) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(K) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(L) "Disciplinary action," unless otherwise stated in this division, means any of the following by the drug enforcement administration or licensing agency of any state or jurisdiction, regardless of whether the action occurred by formal proceeding, consent, settlement, or other agreement:

(1) An action to revoke, suspend, restrict, limit, or refuse to grant or renew a license, registration, or certification;

(2) A summary or emergency suspension of a license, registration or certification, of any length, and any subsequent revision to the action;

(3) An administrative fine or money penalty, taken as a result of a formal proceeding, to include any fine or money penalty connected to the delivery of health care services or taken in conjunction with other adverse licensure, registration or certification actions, such as revocation, suspension, censure, reprimand, or probation;

(4) An action to reprimand or place the license, registration, or certification holder on probation;

(5) The issuance of a corrective action plan only if such issuance is in conjunction with other adverse licensure, registration or certification actions, such as revocation, suspension, reprimand, probation, or surrender;

(6) The withdrawal of a renewal application for licensure, registration or certification while under investigation;

(7) The non-renewal of a license, registration or certification while under investigation or to avoid an investigation;

(8) The surrender or other relinquishment of a license, registration or certification in lieu of a formal sanction against a person's license, registration or certificate, whether permanent or temporary;

(9) In lieu of an adverse licensure, registration or certification action, a licensing agency issues a consent order in which a person agrees not to re-apply for a license, registration, or certification in the future;

(10) An enforceable agreement not to practice or to be placed into inactive or other equivalent status while under investigation or in exchange for not conducting an investigation.

(M) "Distributor of dangerous drugs" or "drug distributor" means the following persons licensed in accordance with section 4729.52 of the Revised Code and division 4729:6 of the Administrative Code:

(1) Wholesale distributors of dangerous drugs, including:

(a) Brokers; and

(b) Virtual wholesalers.

(2) Manufacturers of dangerous drugs.

(3) Outsourcing facilities.

(4) Third-party logistics providers.

(5) Repackagers of dangerous drugs.

(N) "Inpatient" means any person who receives drugs for use while within an institutional facility.

(O) "Outpatient" means any person who receives drugs for use outside of an institutional facility.

(P) "Person" has the same meaning as in division (S) of section 4729.01 of the Revised Code and also includes any individual member, regardless of the percentage of ownership, of any partnership, association, limited liability company, or corporation.

(Q) "Personally furnish" or "personally furnishing" means the final association of a drug with a patient by a prescriber prior to providing the drug to a patient for use outside the prescriber's practice setting.

(R) "Place on probation" means to take action against a license for a period of time determined by the board, which imposes conditions or other requirements, or suspends or otherwise restricts some or all of the activities in which the licensee may engage.

(S) "Readily retrievable," means that records maintained in accordance with this division shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(T) "Refuse to grant or renew" means to deny original or continued licensure for a period of at least twenty-four months. After twenty-four months, or such period of time as the individual board order may require, a person licensed by the board or a person seeking to attain such status by licensure, and whose license the state board of pharmacy has refused to grant or renew, may make application to the board for issuance of a new license. A person that seeks to attain such status by licensure, whose license the state board of pharmacy has refused to grant or renew, must meet all requirements established by the board in rule and as may be set forth in the person's board order.

(U) "Revoke" means to take action against a license rendering such license void and such license shall not be reissued. Revoke is an action that is permanent against the licensee.

(V) "Sale" or "sell" includes any transaction made by any person, whether as principal proprietor, agent, or employee, to do or offer to do any of the following: deliver, distribute, broker, exchange, gift or otherwise give away, or transfer, whether the transfer is by passage of title, physical movement, or both.

(W) "Sample" means a drug or pharmaceutical preparation that would be hazardous to health or safety if used without the supervision of a licensed health professional authorized to prescribe drugs, or a drug of abuse, and that, at one time, had been placed in a container plainly marked as a sample by a manufacturer.

(X) "State" means a state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or a territory or insular possession subject to the jurisdiction of the United States.

(Y) "Suspend" means to take action against a license rendering such license without force and effect for a period of time as determined by the state board of pharmacy. The board may require that an individual whose license or registration has been suspended may not be employed by or work in a facility licensed by the state board of pharmacy to possess or distribute dangerous drugs during such period of suspension.

(Z) "Summary suspension" means to take immediate action against a license without a prior hearing rendering such license without force and effect for a period of time as indicated in section 4729.571 of the Revised Code. The board may suspend a license issued pursuant to Chapter 4729. of the Revised Code by utilizing a telephone conference call to review the allegations and take a vote.

(AA) "Wholesale sale" and "sale at wholesale" mean any sale in which the purpose of the purchaser is to resell the article purchased or received by the purchaser.

Last updated May 19, 2025 at 8:02 AM

History

Effective: May 19, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-1-02 Licensed health professional authorized to prescribe drugs.

(A) The following persons licensed in accordance with Chapters 4715., 4723., 4725., 4729., 4730., 4731., and 4741. of the Revised Code are authorized by law to write prescriptions for drugs or dangerous drugs in the course of the person's professional practice:

(1) Chapter 4715. of the Revised Code: dentist.

(2) Chapter 4725. of the Revised Code: optometrist, if that person holds a current therapeutic pharmaceutical agents certificate as defined in section 4725.01 of the Revised Code.

(3) Chapter 4731. of the Revised Code: doctor of medicine, doctor of osteopathic medicine and surgery, and doctor of podiatry.

(4) Chapter 4741. of the Revised Code: doctor of veterinary medicine.

(5) Chapter 4723. of the Revised Code: advanced practice registered nurse in accordance with paragraph (D) of this rule.

(6) Chapter 4730. of the Revised Code: physician assistant in accordance with paragraph (E) of this rule.

(7) Chapter 4729. of the Revised Code: pharmacist in accordance with paragraph (F) of this rule.

(B) Those persons participating in an approved internship, residency, or fellowship program in this state are authorized to write prescriptions only when acting within the person's scope of employment. Approved internship and residency programs are those accredited by the "Accreditation Council for Graduate Medical Education (ACGME)," "American Osteopathic Association (AOA)," or "Council of Podiatric Medical Education (CPME) of the American Podiatric Medical Association (APMA)." Approved clinical fellowships are those at institutions which have a residency program in the same or a related clinical field which is accredited by the ACGME, the AOA, or the APMA.

(C) A nonresident prescriber whose license is current and in good standing and who is authorized to issue prescriptions for dangerous drugs in the course of the prescriber's professional practice in a state other than Ohio is authorized to write prescriptions in that state for drugs to be dispensed in the state of Ohio. The prescriber shall comply with the requirements of rule 4729:5-5-15 of the Administrative Code.

(D) An advanced practice registered nurse shall prescribe pursuant to the requirements set forth in section 4723.481 of the Revised Code and the rules adopted thereunder.

(E) A physician assistant who holds a valid prescriber number pursuant to section 4730.41 of the Revised Code issued by the state medical board is authorized to prescribe drugs and therapeutic devices in the exercise of physician-delegated prescriptive authority.

(F) A pharmacist who is either:

(1) Authorized to manage drug therapy pursuant to section 4729.39 of the Revised Code when authorized by a consult agreement and to the extent specified in the agreement; or

(2) Authorized to issue prescriptions for dangerous drugs pursuant to Chapter 4729. of the Revised Code.

Last updated July 1, 2024 at 5:24 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Chapter 4729:5-2 Licensure

Ohio Adm.Code 4729:5-2-01 Responsible person - terminal distributor.

(A) Except as provided in paragraph (B) of this rule, for a pharmacy licensed as a terminal distributor of dangerous drugs:

(1) Only a pharmacist may be the responsible person whose name appears on the terminal distributor of dangerous drugs license for a pharmacy as defined in division (A) of section 4729.01 of the Revised Code. A pharmacist shall be the responsible person for no more than one such pharmacy or campus unless granted permission in accordance with paragraph (G) of this rule.

(2) The responsible person shall be responsible for the practice of the profession of pharmacy, including, but not limited to, the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and maintaining all drug records otherwise required.

(3) The person to whom the terminal distributor of dangerous drugs license has been issued and all pharmacists on duty are responsible for compliance with all state and federal laws, regulations, and rules governing the distribution of drugs and the practice of pharmacy.

(B) For an institutional pharmacy licensed as a terminal distributor of dangerous drugs:

(1) Only a pharmacist licensed under section 4729. of the Revised Code may be the responsible person whose name appears on the terminal distributor of dangerous drugs license for an institutional pharmacy. A pharmacist shall be the responsible person for no more than one such pharmacy or campus unless granted permission in accordance with paragraph (G) of this rule.

(2) The responsible person shall be responsible for all of the following:

(a) The practice of the profession of pharmacy performed within the institutional facility, including, but not limited to, the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and maintaining all drug records otherwise required.

(b) The development, implementation, supervision, and coordination of all services provided by the institutional pharmacy.

(c) In conjunction with the appropriate interdisciplinary committees, the development of written policies and procedures which are consistent with this division of the Administrative Code and other applicable federal and state laws, regulations and rules governing the legal distribution of drugs, adherence to these policies and procedures in order to provide for the safe distribution of drugs in all areas of the institutional facility, and making readily retrievable a current copy of these written policies and procedures.

(C) For locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revised Code:

(1) Only a physician authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery may be the responsible person whose name appears on the category III terminal distributor of dangerous drugs with a pain management classification license as defined in section 4729.552 of the Revised Code. A physician shall be the responsible person for no more than one such location unless granted permission in accordance with paragraph (G) of this rule. A physician shall not be designated the responsible person for a location licensed as a category III terminal distributor of dangerous drugs with a pain management classification unless the physician will be physically present at the location for a sufficient amount of time to provide adequate supervision.

(2) The responsible person shall submit to a criminal records check in accordance with section 4776.02 of the Revised Code.

(3) The responsible person for locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revised Code must meet one of the following requirements:

(a) Hold current subspecialty certification in pain management by the American board of medical specialties, or hold a current certificate of added qualification in pain management by the American osteopathic association bureau of osteopathic specialists;

(b) Hold current subspecialty certification in hospice and palliative medicine by the American board of medical specialties, or hold a current certificate of added qualification in hospice and palliative medicine by the American osteopathic association bureau of osteopathic specialists;

(d) Hold current board certification by the American board of interventional pain physicians; or

(e) Hold current board certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology by the American board of medical specialties or hold current primary certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology by the American osteopathic association bureau of osteopathic specialists.

(4) The person to whom the category III terminal distributor of dangerous drugs license with a pain management clinic classification has been issued, the responsible person and all licensed health professionals practicing at that location are responsible for compliance with all state and federal laws, regulations, and rules governing the operation of a pain management clinic and prescribing of controlled substances.

(D) For locations licensed as a category III terminal distributor of dangerous drugs with an office-based opioid treatment classification under section 4729.553 of the Revised Code:

(1) Only a physician or certified nurse practitioner who meets the following may be the responsible person whose name appears on the category III terminal distributor of dangerous drugs with an office-based opioid treatment classification license as defined in section 4729.553 of the Revised Code:

(a) The physician is authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery or the certified nurse practitioner is designated as a certified nurse practitioner in accordance with section 4723.42 of the Revised Code and rules adopted by the board of nursing; and

(b) The physician or certified nurse practitioner possesses a waiver to prescribe or personally furnish buprenorphine under the Drug Addiction Treatment Act of 2000 (DATA 2000) (2/20/2017).

(2) The responsible person shall submit to a criminal records check in accordance with section 4776.02 of the Revised Code.

(3) A physician or certified nurse practitioner shall not be designated the responsible person for a location licensed as a category III terminal distributor of dangerous drugs with an office-based opioid treatment classification unless the physician or certified nurse practitioner will be physically present at the location for at least fifteen hours per week. If the facility is not open more than fifteen hours per week, the minimum amount of on-site supervision shall be at least fifty per cent of the total hours the facility is open, as reported to the board by the licensee on the application. Any changes to the licensee's hours of operation shall be reported to the board, in a manner determined by the board, within three business days.

(a) The hour requirements of this paragraph do not apply if either:

(i) The responsible person is unable to meet the requirements due to a documented illness or emergency and there is another physician or certified nurse practitioner on-site who meets the requirements of paragraph (C)(1) of this rule who can provide on-site supervision in accordance with the requirements described in this paragraph. The physician or certified nurse practitioner shall assume all responsibilities for compliance with this rule in the absence of the responsible person.

(ii) The location is closed for a state or federal holiday or other documented reason.

(4) The person to whom the category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification has been issued, the responsible person and all licensed health professionals practicing at that location are responsible for compliance with all state and federal laws, regulations, and rules regulating the operation of an office-based opioid treatment facility and prescribing of controlled substances.

(E) For all locations licensed as a terminal distributor of dangerous drugs:

(1) A location licensed as a terminal distributor of dangerous drugs must have a responsible person at all times.

(2) When there is a change of responsible person, the state board of pharmacy shall be notified within ten days of the effective date of the appointment of the new responsible person in a manner determined by the board. For a limited terminal distributor of dangerous drugs license, the notification shall include a drug list required in accordance with agency 4729 of the Administrative Code.

(3) A complete inventory, pursuant to 21 CFR 1304.11 of the Code of Federal Regulations (9/9/2014) and rule 4729:5-3-07 of the Administrative Code, shall be taken of the controlled substances on hand by the new responsible person on the effective date of the change of responsible person. The new responsible person shall be responsible for completing and maintaining this inventory record at the location licensed as a terminal distributor of dangerous drugs.

(4) The responsible person to whom the terminal distributor of dangerous drugs license has been issued and all licensed health professionals on duty are responsible for compliance with all state and federal laws, regulations, and rules governing the distribution of dangerous drugs.

(5) A responsible person must be physically present at the location for a sufficient amount of time to provide supervision and control of dangerous drugs on-site.

(6) The responsible person shall be responsible for ensuring the terminal distributor of dangerous drugs requirements are met, including, but not limited to, the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and maintaining all drug records otherwise required.

(7) The board of pharmacy shall issue a resolution providing the credential types required for the responsible person of each classification/business type of terminal distributor of dangerous drugs license. Only individuals that meet the credentials specified may be the responsible person for that classification/business type. The resolution shall be updated as necessary and shall be made available on the board's web site (www.pharmacy.ohio.gov).

(F) Unless otherwise approved by the board, a terminal distributor shall not have a responsible person who:

(1) Has been denied the right to work in any facility by the state board of pharmacy as part of an official order of the board.

(2) Has been denied the right to work in such a facility by another professional licensing board/agency as part of an official order of that board/agency.

(3) Has committed an act that constitutes a disqualifying offense, regardless of the jurisdiction in which the act was committed.

(4) Has been subject to any of the following:

(a) A finding by a court of the person's eligibility for intervention in lieu of conviction; or

(b) A finding by a court of the person's eligibility for treatment or intervention in lieu of conviction in another jurisdiction.

(5) Has been granted entry into a diversion program, deferred prosecution program, or the equivalent thereof.

(6) Cannot practice according to acceptable and prevailing standards of care by reason of mental illness or physical illness, including, but not limited to, physical deterioration that adversely affects cognitive, motor, or perceptive skills.

(7) Is addicted to or abusing alcohol or drugs.

(8) Has been excluded from participation in medicare or a state health care program.

(9) Has been denied a license or registration by the drug enforcement administration or appropriate issuing body of any state or jurisdiction.

(10) Has been the subject of any of the following by the drug enforcement administration or licensing agency of any state or jurisdiction:

(a) A disciplinary action that resulted in the suspension, probation, surrender or revocation of the person's license or registration; or

(b) A disciplinary action that was based, in whole or in part, on the person's inappropriate prescribing, dispensing, diverting, administering, storing, securing, personally furnishing, compounding, supplying or selling a controlled substance or other dangerous drug.

(G) Written requests for being a responsible person at more than one location pursuant to this rule must be submitted to the state board of pharmacy in a manner determined by the board. The executive director or the director's designee shall have the authority to temporarily approve or deny a request for being a responsible person at more than one location for a period not to exceed sixty days. The full board will review requests the executive director or the director's designee has temporarily approved at the next scheduled board meeting. A terminal distributor of dangerous drugs whose request has been denied either by the executive director, the director's designee or the board will be provided with a written explanation of denial and allowed one opportunity to resubmit its request to address the identified concerns. The board may impose conditions on all approved requests, including requirements that requests be submitted for reapproval at intervals determined by the board.

Last updated July 14, 2026 at 2:31 PM

History

Effective: April 25, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-2-02 Terminal distributor of dangerous drugs licensing and renewal.

(A) All terminal distributor of dangerous drugs licenses issued pursuant to Chapter 4729. of the Revised Code shall expire on the thirty-first day of March of every odd-numbered year. A license shall be renewed biennially according to the provisions of sections 4729.54 and 4729.55 of the Revised Code and the standard renewal procedure of Chapter 4745. of the Revised Code.

(B) An initial terminal distributor of dangerous drugs license issued on or after the thirtieth day of January of every odd-numbered year shall receive an expiration date of the thirty-first day of March of the next odd-numbered year.

(C) A terminal distributor of dangerous drugs who seeks to renew a license shall submit an application for renewal and pay the required fee in accordance with section 4729.54 of the Revised Code, including any transaction fee as required by section 125.18 of the Revised Code, on or before the license expiration date.

(D) A terminal distributor of dangerous drugs who has experienced a change in responsible person pursuant to rule 4729:5-2-01 of the Administrative Code and has not yet reported such change to the board, shall submit the required notification prior to submitting a renewal application.

(E) A terminal distributor of dangerous drugs who has experienced a change in description pursuant to rule 4729:5-2-03 of the Administrative Code and has not yet reported such change to the board, shall submit the required application and fee in lieu of a renewal application.

An application and fee submitted pursuant to rule 4729:5-2-03 of the Administrative Code during the renewal period will qualify as a renewal application and be awarded an expiration date in accordance with paragraph (A) of this rule.

(F) The required fees for initial licensure and biennial renewal of a terminal distributor of dangerous drugs license shall be in accordance with sections 4729.55 and 125.18 of the Revised Code.

(G) Licensure pursuant to section 4729.54 of the Revised Code is not applicable to any facility owned or operated by the following:

(1) The United States department of defense;

(2) The United States department of veterans affairs; or

(3) Any other federal agency.

(H) A terminal distributor of dangerous drugs licensed pursuant section 4729.54 of the Revised Code that fails to renew its license in accordance with this division of the Administrative Code is prohibited from engaging in any authorized activity of a terminal distributor of dangerous drugs until a valid license is issued by the board.

(I) A terminal distributor of dangerous drugs that fails to renew its license by the expiration date is considered lapsed and may be reinstated upon receipt of a renewal application, fee, and penalty as specified in sections 4729.54 and 125.18 of the Revised Code.

(J) A terminal distributor of dangerous drugs that has lapsed for more than sixty days after its expiration date is considered expired and may be reinstated upon receipt of a reinstatement application and fee as specified in sections 4729.54 and 125.18 of the Revised Code. A terminal distributor filing a reinstatement application must meet the requirements of this chapter and section 4729.55 of the Revised Code.

(K) Paragraphs (D) and (E) of this rule do not limit the board from taking disciplinary action pursuant to rule 4729:5-4-01 of the Administrative Code against a licensee for failure to comply with the requirements of Chapter 4729:5-2 of the Administrative Code.

Last updated March 7, 2024 at 7:45 AM

History

Effective: March 7, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-2-03 Change in description of a terminal distributor of dangerous drugs.

(A) Any change in the ownership, business or trade name, category, or address of a terminal distributor of dangerous drugs requires an application and required fee. The application and required fee shall be submitted within thirty days of any change in the ownership, business or trade name, category, or address.

(B) A change of ownership includes any of the following:

(1) For all terminal distributors of dangerous drugs:

(a) Any business entity change from its original form, as licensed, to a sole proprietorship, partnership, limited liability company, corporation, or any other business entity.

(b) Two wholly owned subsidiaries of a parent company are merged.

(c) A currently licensed terminal distributor is purchased or operated by a different business entity than what is listed on the original application, even if the location maintains the original "doing business as" (DBA) and/or responsible person.

(2) For corporations:

(a) Except as provided in paragraph (B)(2)(d) of this rule, a change of controlling interest of ten per cent or more of a licensed corporation's outstanding shares of voting stock.

(b) An existing corporation ceases, and a new corporation or other business entity is formed.

(c) An existing corporation continues and there is a one hundred per cent stock purchase by another corporation or other business entity.

(d) For publicly traded corporations, a routine sale of stock is not a change of ownership.

A publicly traded corporation is a company that has listed itself on at least one public stock exchange or has issued securities and is subject to public reporting requirements.

(3) For partnerships, any partnership change, other than that which was originally licensed.

(a) A partnership change is deemed to have occurred when:

(i) There is an addition of one or more partners in a partnership to which a license is issued.

(ii) The entity is sold, and the sale becomes final.

(b) A transfer of a portion of ownership among existing partners is not a change of ownership, if there is no addition of a partner.

(4) For a limited liability company, any membership change of a limited liability company, other than that which was originally licensed.

(a) A membership change is deemed to have occurred when:

(i) There is an addition of one or more members in a company to which a license is issued.

(ii) The entity is sold, and the sale becomes final.

(b) For limited liability companies, a transfer of a portion of ownership among existing members is not a change of ownership, if there is no addition of a member.

(5) Any other business model change, as determined by the board to be a change of ownership.

(C) If any change of ownership in accordance with paragraph (B) of this rule results in a new or different DBA or a new or different employer identification number (EIN), an application and fee is required.

(D) A change of ownership in accordance with this rule may result in the issuance of a new license.

(E) A change of ownership, as described in paragraph (B) of this rule, of a licensee's parent or holding company which does not exercise direct control of the licensed entity, shall not require an application, fee, or new license number.

(F) A change of address includes the physical relocation of the licensee's operations and location of the drug stock. This shall include a change of suites within an existing building or campus.

(G) A change of address that results from a change within a local government entity or United States postal service (U.S.P.S.) that does not include any physical relocation of the licensee's operations shall not require an application and fee. The licensee shall submit written notification to the board, in a manner determined by the board, indicating the change of address.

Last updated October 1, 2024 at 9:19 AM

History

Effective: October 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-2-04 Procedure for discontinuing business as a terminal distributor of dangerous drugs.

(A) A terminal distributor of dangerous drugs who plans to discontinue business activities shall file a notice with the board of pharmacy. The notice shall be submitted, in a manner determined by the board, within thirty days of discontinuation of business as a terminal distributor of dangerous drugs. This notice shall include the following information:

(1) The name, address, and license number of the terminal distributor discontinuing business.

(2) The name, address, and license number of the terminal distributor or other authorized entity where the dangerous drugs will be transferred or sold, if applicable.

(3) The name and address of the secured location where the records of purchase and sale will be kept in accordance with this division of the Administrative Code.

(4) The proposed date of discontinuing business.

(B) A licensee discontinuing business may do one or more of the following:

(1) Conduct a one-time transfer or sale of dangerous drug inventory and patient records to another licensed terminal distributor of dangerous drugs or an entity exempted under section 4729.541 of the Revised Code.

The terminal distributor of dangerous drugs discontinuing business shall provide an invoice or transfer record to the purchaser or recipient that contains the name, strength, dosage form, and quantity of the dangerous drugs transferred or sold; the name and address of the terminal distributor of dangerous drugs that is discontinuing business; the name and address of the location where the drugs were transferred or sold; and the date of transfer or sale. All transfers or sales shall be conducted on or before the proposed date of discontinuing business submitted in accordance with paragraph (A) of this rule.

(2) Disposal of its stock of dangerous drugs in accordance with the requirements of Chapter 4729:5-3 of the Administrative Code.

The terminal distributor that is discontinuing business shall create a record of such disposal in accordance with the applicable record keeping provisions of Chapter 4729:5-5 of the Administrative Code. Disposal of inventory shall be conducted on or before the proposed date of discontinuing business submitted in accordance with paragraph (A) of this rule.

(a) All patient-specific drug stock maintained by the terminal distributor of dangerous drugs in accordance with rule 4729:5-3-24 of the Administrative Code shall be provided to the patient on or before the proposed date of discontinuing business submitted in accordance with paragraph (A) of this rule.

(b) Any patient-specific drug stock that cannot be provided to the patient shall be disposed of on or before the proposed date of discontinuing business submitted in accordance with paragraph (A) of this rule.

(3) Pursuant to paragraph (F) of this rule, a person or entity that is exempted from licensure in accordance with section 4729.541 of the Revised Code may maintain dangerous drugs on-site that do not require licensure as a terminal distributor of dangerous drugs to possess.

(C) On the date of discontinuing business and prior to any disposal conducted in accordance with paragraph (B) of this rule, a complete inventory of all controlled substances being transferred, or disposed of, in accordance with rule 4729:5-3-01 of the Administrative Code, shall be conducted. The inventory shall list the name, strength, dosage form, and quantity of all controlled substances transferred, sold, or disposed.

This inventory shall serve as the final inventory of the licensee discontinuing business and the initial inventory of the licensee to whom the controlled substances are being transferred. A copy of the inventory shall be included in the records of each licensee involved in the transfer.

(D) A terminal distributor of dangerous drugs licensed as a pharmacy that is permanently closing shall:

(1) Provide notification, using the information on file with the pharmacy, to each patient who has filled a prescription within the previous six months. This notification must be made a minimum of fifteen calendar days prior to closing and must include:

(a) The last day the pharmacy will be open;

(b) Name, address, and telephone number of the pharmacy that will take possession of the pharmacy records or the person who will serve as the custodian of records;

(d) The last day a transfer may be initiated.

(2) The notification shall be made via:

(a) Direct mail, e-mail, or text message; and

(b) Posting a closing notice on each pharmacy entrance, on each telephone greeting, and pharmacy-operated internet (e.g., website, social media, mobile applications).

(3) Provide any new patients filling prescriptions during the fifteen-calendar day period prior to the pharmacy closing with written notification that includes:

(a) The last day the pharmacy will be open;

(b) Name, address and telephone number of the pharmacy to which pharmacy records will be transferred or the person who will serve as the custodian of pharmacy records;

(d) The last day a transfer may be initiated.

(E) Except as provided in paragraph (F) of this rule, a terminal distributor of dangerous drugs that has had its license suspended or revoked shall dispose of and/or transfer all dangerous drugs within five days of receiving notice from the board of such a suspension or revocation.

(1) Disposal of drug stock. A terminal distributor of dangerous drugs that has had its license suspended or revoked shall dispose of all drug stock maintained by the terminal distributor.

(a) Non-controlled dangerous drugs shall be disposed of in accordance with rule 4729:5-3-06 of the Administrative Code. To demonstrate compliance with the requirements of Chapter 4729. of the Revised Code, the suspended or revoked licensee shall maintain a record for all non-controlled drugs disposed. The records shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed; the date of disposal; the method of disposal; and the identification of the licensed health care professional that performed the disposal.

(b) Controlled substances shall be disposed in accordance with rule 4729:5-3-01 of the Administrative Code. To demonstrate compliance with the requirements of Chapter 4729. of the Revised Code, the suspended or revoked licensee shall maintain records for all controlled substance drugs disposed in accordance with rule 4729:5-3-01 of the Administrative Code.

(c) All disposal records shall be maintained for three years from the date of disposal for immediate inspection by an agent, officer, or inspector of the board to demonstrate compliance with section 4729.51 of the Revised Code.

(2) One-time transfer or sale of drug stock. Except as provided in paragraph (E)(3) of this rule, a terminal distributor of dangerous drugs that has had its license suspended or revoked may conduct a one-time transfer or sale of dangerous drugs to another terminal distributor of dangerous drugs or an entity exempted under section 4729.541 of the Revised Code. Any dangerous drugs that are not transferred or sold shall be disposed of in accordance with paragraph (E)(1) of this rule.

The terminal distributor of dangerous drugs that has had its license suspended or revoked shall provide the following records to the purchaser or recipient:

(a) An invoice or transfer record that contains the name, strength, dosage form, and quantity of the dangerous drugs transferred or sold; the name and address of the terminal distributor of dangerous drugs that is suspended or revoked; the name and address of the location where the drugs were transferred or sold; and the date of transfer or sale; and

(b) A complete inventory of all controlled substances being transferred or sold in accordance with rule 4729:5-3-01 of the Administrative Code. The inventory shall list the name, strength, dosage form, and quantity of all controlled substances transferred, sold, or disposed.

(3) A terminal distributor of dangerous drugs listed in paragraph (E)(2) of this rule that receives a one-time transfer or sale of drug stock in accordance with this rule may conduct a one-time transfer or sale of dangerous drugs back to the original owner of the drugs if all the following conditions are satisfied:

(a) The original owner's terminal distributor of dangerous drugs license has been reinstated by the board and there are no limitations or restrictions on the license.

(b) The one-time transfer or sale back to the original owner is conducted within five days of reinstatement of the terminal distributor of dangerous drugs license.

(c) The drug stock received from the original owner has been stored separately from the stock of drugs maintained by the terminal distributor of dangerous drugs conducting the transfer or sale to avoid any comingling of inventory.

(d) The terminal distributor of dangerous drugs conducting the transfer or sale maintains a record of the transfer or sale for a period or three years in a readily retrievable format. The record shall include the name, strength, dosage form, and quantity of the dangerous drug transferred or sold; the address of the location where the drugs were transferred or sold; and the date of transfer or sale.

(e) The terminal distributor of dangerous drugs receiving the drugs maintains a record of the transfer or sale for a period of three years in a readily retrievable format. The record shall include the name, strength, dosage form, and quantity of the dangerous drugs received; the name and address of the seller; the name and address of the recipient; and the date of receipt.

(F) A terminal distributor of dangerous drugs that meets the exemptions specified in division (A)(1) to (A)(3) of section 4729.541 of the Revised Code may maintain dangerous drugs on-site that do not require licensure as a terminal distributor of dangerous drugs. This shall not include any of the following:

(1) A schedule I, II, III, IV, or V controlled substance, as defined in section 3719.01 of the Revised Code; and

(2) Except for dangerous drugs that meet the exemptions listed in paragraph (A) of rule 4729:7-3-02 of the Administrative Code, dangerous drugs that are compounded or used for the purpose of compounding including bulk drug substances and active pharmaceutical ingredients used in compounding.

Last updated May 15, 2026 at 7:36 AM

History

Effective: May 15, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-2-05 Notification of Accessible Services.

(A) Every outpatient pharmacy providing pharmacy services in this state shall report to the state board of pharmacy, in a manner determined by the board, the following information on accessible services provided by the pharmacy within ninety days of the effective date of this rule:

(1) The type of language translation services, including translated prescription labels, for patients who are of limited English proficiency;

(2) The type of services available for patients who are hard of hearing; and

(3) The type of services available for patients with low vision.

(B) As part of the licensure and renewal process established in rule 4729:5-2-02 of the Administrative Code, an outpatient pharmacy providing pharmacy services in this state shall submit information on the accessible services listed in paragraph (A) of this rule that are provided by the pharmacy.

(C) An outpatient pharmacy required to submit notification to the board in accordance with this rule shall notify the board within thirty days of any change in the accessible services provided by the pharmacy.

(D) Except as provided in paragraph (E) of this rule, a pharmacy that reports it offers accessible services shall be required to provide those services to patients upon request.

(E) Paragraph (D) of this rule does not apply if the pharmacy experiences a temporary software or equipment failure of the accessible service offered.

Last updated August 23, 2024 at 7:53 AM

History

Effective: August 23, 2024
Promulgated Under: 119.03

Chapter 4729:5-3 General Provisions

Ohio Adm.Code 4729:5-3-01 Disposal of controlled substances.

(A) As used in this rule:

(1) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(2) "Controlled substance proof-of-use sheet" means a record that captures, at a minimum, the following information:

(a) Date;

(b) Patient name;

(d) Drug strength;

(e) Quantity; and

(f) The positive identification of the individuals authorized by this rule who are responsible for removing the dangerous drugs from the medication cart, or other storage area, and transferring the drugs to the secure storage area.

(3) "Non-retrievable" means the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance's physical or chemical condition or state through irreversible means and thereby renders the dangerous drugs which are controlled substances unavailable and unusable for all practical purposes. The process to achieve a non-retrievable condition or state may be unique to a substance's chemical or physical properties. A dangerous drug which is a controlled substance is considered non-retrievable when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. The purpose of destruction is to render the controlled substance(s) to a non-retrievable state and thus prevent diversion of any such substance to illicit purposes.

(4)

(a) "Positive identification" means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following:

(i) A manual signature on a hard copy record;

(ii) A magnetic card reader;

(iii) A bar code reader;

(iv) A biometric method;

(v) A proximity badge reader;

(vi) A board approved system of randomly generated personal questions;

(vii) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who performed the action requiring positive identification. The printout must be maintained for three years and made readily retrievable; or

(viii) Other effective methods for identifying individuals that have been approved by the board.

(b) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system.

(5) "State or local correctional facility" means any of the following:

(a) A "state correctional institution," as defined in section 2967.01 of the Revised Code;

(b) A "local correctional facility," as defined in section 2903.13 of the Revised Code.

(B) A terminal distributor of dangerous drugs shall dispose of controlled substance dangerous drugs in accordance with 21 C.F.R. 1317 (9/25/2023). The method of destruction must render the controlled substances to a state of non-retrievable. Records of controlled substance destruction that are required pursuant to 21 C.F.R. 1304 (9/25/2023) shall be maintained for a minimum of three years and made readily retrievable.

(1) If a long term care facility uses a method of destruction pursuant to 21 C.F.R. 1317 (9/25/2023), the controlled substances transferred to a collection receptacle or mail-back envelope must be completed by the director of nursing and witnessed by a nurse licensed in accordance with Chapter 4723. of the Revised Code. The amount of controlled substances transferred to the receptacle or mail-back envelope and the method of disposal used must be documented with the positive identification of both individuals on the corresponding controlled substance proof-of-use sheet.

(C) If a pharmacy is servicing a long term care facility or a consultant pharmacist is employed by a long term care facility and is having a pharmacist engage in the on-site destruction of ultimate user (i.e., patient-owned) controlled substances in the custodial care of nursing staff, the pharmacy or consultant pharmacist shall have policies and procedures in place to ensure compliance with and shall comply with all the following:

(1) Upon discontinuation of a patient's use of a controlled substance medication, a nurse and director of nursing, or other pharmacy or pharmacist-approved supervisory nurse, must document the removal of the patient's medication from the medication cart or storage area and record the transfer of the drugs to a secure storage area for disposal.

(2) The record of the controlled substances removed from the medication cart, or other area of storage, for disposal shall be made on a controlled substance proof-of-use sheet. The proof-of-use sheet shall be maintained on-site at the location licensed as a terminal distributor of dangerous drugs for a minimum of three years from the date of removal and made readily retrievable.

(3) An Ohio licensed pharmacist or the director of nursing and another pharmacy or pharmacist-approved supervisory level nurse may destroy an ultimate user's controlled substances using an on-site method at the location licensed as a terminal distributor of dangerous drugs. Both individuals shall personally witness and document the destruction of the controlled substance medication pursuant to paragraph (C)(4) of this rule. The on-site method does not have to meet the definition of non-retrievable but must render the drug unavailable and unusable.

(4) A record of controlled substances destroyed shall be made containing the date of destruction, patient name, drug name, drug strength, quantity, method of destruction and the positive identification of the two individuals listed in paragraph (C)(3) of this rule responsible for the destruction.

(5) The record of controlled substance destruction pursuant to paragraph (C)(4) of this rule shall be maintained on-site at the location licensed as a terminal distributor of dangerous drugs for a minimum of three years from the date of destruction and made readily retrievable.

(6) Controlled substances shall be destroyed pursuant to this paragraph no later than ten days from the date the patient's controlled substance medication is removed from the medication cart or storage area in accordance with paragraph (C)(1) of this rule.

(D) A state or local correctional facility may engage in the on-site destruction of ultimate user (i.e., patient-owned) controlled substances in the custodial care of nursing staff, as follows:

(1) The correctional facility shall be licensed as a category III terminal distributor of dangerous drugs.

(2) The responsible person shall have policies and procedures in place to ensure compliance with and shall comply with all the following:

(a) Upon discontinuation of a patient's use of a controlled substance medication, the responsible person, director of nursing or a licensed pharmacist and another responsible person-approved nurse or corrections officer must document the removal of the patient's medication from the medication cart or storage area and record the transfer of the drugs to a secure storage area for disposal.

(b) The record of the controlled substances removed from the medication cart, or other area of storage, for disposal shall be made on a controlled substance proof-of-use sheet. The proof-of-use sheet shall be maintained on-site at the location licensed as a terminal distributor of dangerous drugs for a minimum of three years from the date of removal and made readily retrievable.

(c) The responsible person, director of nursing, or a licensed pharmacist and another responsible person-approved nurse or corrections officer may destroy ultimate user controlled substances using an on-site method at the location licensed as a terminal distributor of dangerous drugs. Both individuals shall personally witness and document the destruction of the controlled substance medication pursuant to paragraph (D)(2)(d) of this rule. The on-site method does not have to meet the definition of non-retrievable but must render the drug unavailable and unusable.

(d) A record of controlled substances destroyed shall be made containing the date of destruction, patient name, drug name, drug strength, quantity, method of destruction and the positive identification of the two individuals listed in the paragraph (D)(2)(c) of this rule responsible for the destruction. The record of controlled substance destruction shall be maintained on-site at the location licensed as a terminal distributor of dangerous drugs for a minimum of three years from the date of destruction and made readily retrievable.

(e) Controlled substances shall be destroyed no later than ten days from the date the patient's controlled substance medication is removed from the medication cart or storage area in accordance with paragraph (D)(2)(a) this rule.

(E) The unused portion of a controlled substance resulting from administration to a patient from a licensee's stock or emergency supply may be destroyed using an on-site method by any person legally authorized under Chapters 3719. and 4729. of the Revised Code and this division of the Administrative Code to possess controlled substance dangerous drugs. The on-site method does not have to meet the definition of non-retrievable but must render the drug unavailable and unusable. A record of such destruction shall be made in accordance with 21 C.F.R. 1304 (9/25/2023) and shall be maintained for a minimum of three years from the date of destruction and made readily retrievable to the board of pharmacy upon request.

Last updated July 1, 2024 at 5:25 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-02 Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents.

(A) A terminal distributor of dangerous drugs shall notify the following upon discovery of the theft or significant loss of any dangerous drug or controlled substance, including drugs in transit that were either shipped from or to the licensed location:

(1) The state board of pharmacy, by telephone or other method determined by the board, immediately upon discovery of the theft or significant loss;

(2) If a controlled substance, the drug enforcement administration (DEA) pursuant to 21 C.F.R. 1301.76 (June 22, 2023);

(3) Law enforcement authorities pursuant to section 2921.22 of the Revised Code.

(B) The theft or significant loss of controlled substances shall be reported by a licensee using the federal DEA report form regardless if the controlled substances are subsequently recovered and/or the responsible parties are identified and action is taken. Information reported in the federal form regarding such theft or significant loss shall be filed with the state board of pharmacy, in a manner determined by the board, by the licensee within forty-five days following the discovery of such theft or significant loss.

(1) An exemption may be obtained upon sufficient cause if the federal form cannot be filed within forty-five days.

(2) A request for a waiver of the forty-five-day limit must be requested in a manner determined by the board.

(C) The theft or significant loss of non-controlled dangerous drugs shall be reported to the state board of pharmacy, in a manner determined by the board, by the licensee within forty-five days following the discovery of such theft or significant loss of non-controlled dangerous drugs. The report shall be filed regardless if the dangerous drugs are subsequently recovered and/or the responsible parties are identified and action is taken.

(1) An exemption may be obtained upon sufficient cause if the form cannot be filed within forty-five days.

(2) A request for a waiver of the forty-five-day limit must be requested in a manner determined by the board.

(D) A terminal distributor of dangerous drugs shall, immediately upon discovery, notify the state board of pharmacy, in a manner determined by the board, and law enforcement authorities of any theft or loss of uncompleted prescription blank(s) used for writing a prescription, written prescription order(s) not yet dispensed and original prescription order(s) that have been dispensed.

(E) A terminal distributor of dangerous drugs shall, immediately upon discovery, notify the state board of pharmacy, in a manner determined by the board, law enforcement authorities and the drug enforcement administration (DEA) pursuant to 21 C.F.R. 1305.16 (September 30, 2019) of the theft or loss of any DEA form 222.

Last updated August 10, 2026 at 7:51 AM

History

Effective: August 8, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-03 Inspections and corrective actions.

(A) Pursuant to section 3719.13 of the Revised Code, an entity licensed by the state board of pharmacy as a terminal distributor of dangerous drugs is subject to an on-site inspection by the board. An authorized board employee may, without notice, carry out an on-site inspection or investigation of an entity licensed by the board. Upon verification of the board employee's credentials, the employee shall be permitted to enter the licensed entity.

(B) Submission of an application for a license as a terminal distributor of dangerous drugs with the state board of pharmacy constitutes permission for entry and on-site inspection by an authorized board employee.

(C) If an employee of the state board of pharmacy identifies a violation specified in paragraph (D) of this rule, the employee may provide written notice, in a manner determined by the board, of the nature of the observed violations to the responsible person on the license or application. The licensee or applicant may also be subject to disciplinary actions pursuant to Chapter 4729. of the Revised Code and this division of the Administrative Code.

(D) Violations may include any of the following:

(1) Violating any rule of the board;

(2) Violating any provision of Chapter 4729. of the Revised Code;

(3) Violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C. 301, or Chapter 3715. of the Revised Code; or

(4) Violating any provision of the federal drug abuse control laws or regulations or Chapter 2925. or 3719. of the Revised Code.

(E) The licensee or applicant shall submit to the board within thirty days of a written notice provided in accordance with paragraph (C) of this rule, in a manner determined by the board, either of the following:

(1) The action(s) the licensee or applicant has taken to correct the violation(s) and the date of implementation of the corrective action(s); or

(2) An explanation disputing the observed violations.

Last updated July 1, 2024 at 5:26 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-04 Verification of licensure prior to sale or purchase.

(A) Before a terminal distributor of dangerous drugs may purchase dangerous drugs at wholesale, the terminal distributor shall query the board's online roster (available on the board's website: www.pharmacy.ohio.gov) to confirm any of the following:

(1) The seller is licensed to engage in the sale of dangerous drugs in accordance with section 4729.52 of the Revised Code; or

(2) The seller is licensed to engage in the occasional sale or distribution of dangerous drugs at wholesale in accordance with rule 4729:5-3-09 of the Administrative Code.

(B) If no documented query is conducted before a purchase is made, it shall be presumed that the purchase of dangerous drugs by the terminal distributor is in violation of section 4729.51 of the Revised Code.

If a licensed terminal distributor of dangerous drugs conducts a documented query at least annually and relies on the results of the query in purchasing dangerous drugs, the terminal distributor shall be deemed not to have violated section 4729.51 of the Revised Code in making the purchase.

(C) Before a terminal distributor of dangerous drugs may make a sale of dangerous drugs pursuant to rule 4729:5-3-09 of the Administrative Code, the terminal distributor shall query the board's online roster (available on the board's website: www.pharmacy.ohio.gov) to determine if the purchaser is licensed as either:

(1) A terminal distributor of dangerous drugs.

For a limited terminal distributor of dangerous drugs license, a terminal distributor shall also review a current version of the licensee's drug list to ensure the purchaser is authorized to possess the drugs ordered.

(2) A distributor of dangerous drugs in accordance with division 4729:6 of the Administrative Code.

(D) Paragraph (C) of this rule does not apply when a terminal distributor sells or distributes dangerous drugs at wholesale to any of the following:

(1) A terminal distributor, manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor that is located in another state, is not engaged in the sale of dangerous drugs within this state, and is actively licensed to engage in the sale of dangerous drugs by the state in which the distributor conducts business; or

(2) Any of the exempted persons described in section 4729.541 of the Revised Code.

(3) The sale, transfer, or distribution of dangerous drugs to an EMS organization from an institutional pharmacy or facility licensed as a terminal distributor of dangerous drugs that is owned or operated by a hospital for purposes of restocking an emergency medical services vehicle if the institutional pharmacy or facility conducts an annual query to ensure the EMS organization is properly licensed as a terminal distributor of dangerous drugs.

(4) An intracompany transfer made in accordance with rule 4729:5-3-09 of the Administrative Code, if the entity engaged in the transfer conducts an annual query to ensure each location is properly licensed as a terminal distributor of dangerous drugs.

(E) A terminal distributor of dangerous drugs may make a sale of a dangerous drug to any of the exempted persons described in section 4729.541 of the Revised Code in accordance with rule 4729:5-3-09 of the Administrative Code and shall ensure the purchaser meets the exemption criteria. To confirm a purchaser meets the exemption criteria, the terminal drug distributor shall comply with all the following:

(1) Provide the purchaser, in a manner determined by the board, the requirements in Ohio law of when a purchaser shall hold a license as a terminal distributor of dangerous drugs;

(2) If the purchaser is a prescriber, verify the prescriber is appropriately licensed in this state to prescribe drugs or dangerous drugs or drug therapy related devices in the course of the individual's professional practice;

(3) Require the purchaser who claims an exemption to the terminal distributor of dangerous drug licensing requirement to annually attest in writing, which may include an electronic signature, that the purchaser meets the licensing exemptions in section 4729.541 of the Revised Code; and

(4) Ensure that all attestations are maintained by the terminal distributor for a period of three years following the date the attestation is signed by the purchaser.

Last updated May 19, 2025 at 8:02 AM

History

Effective: May 19, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-05 Confidentiality of patient records.

(A) Records relating to the practice of pharmacy, the administration of drugs, or any patient specific drug transaction are not a public record. A person having custody of, or access to, such records shall not divulge the contents thereof, or provide a copy thereof, to anyone except:

(1) The patient, or owner if the patient is an animal, for whom the prescription or medication order was issued.

(2) The prescriber who issued the prescription or medication order, or a subsequent treating prescriber.

(3) Licensed health care personnel who are responsible for the care of the patient.

(4) A member, inspector, agent, or investigator of the state board of pharmacy or any federal, state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug.

(5) An agent of an Ohio licensing agency that is responsible for the licensure or registration of a health professional authorized to prescribe drugs as defined in section 4729.01 of the Revised Code when enforcing that agency's chapter of the Revised Code.

(6) A state or federal agency charged with the responsibility of providing medical care (i.e. medicaid, medicare, workers' compensation, etc.) for the patient upon a written request by an authorized representative of the agency requesting such information.

(7) An agent of a medical insurance company who provides prescription insurance coverage to the patient upon authorization and proof of insurance by the patient or proof of payment by the insurance company for those medications whose information is requested.

(8) An agent who contracts with the terminal distributor of dangerous drugs as a "business associate" in accordance with the regulations promulgated by the secretary of the United States department of health and human services pursuant to the federal standards for privacy of individually identifiable health information.

(9) Any person, other than those listed in paragraphs (A)(1) to (A)(8) of this rule, only when the patient has given consent for such disclosure in writing. Any consent must be signed by the patient and dated. Any consent for disclosure is valid until rescinded by the patient.

In an emergency, the terminal distributor of dangerous drugs may disclose the information when, in the professional judgment of the pharmacist or healthcare provider, it is deemed to be in the best interest of the patient. A pharmacist or healthcare provider making an oral disclosure in an emergency situation must prepare a written memorandum showing the patient's name, the date and time the disclosure was made, the nature of the emergency, and the names of the individuals by whom and to whom the information was disclosed.

(B) Testimonial privilege is not waived for any communication between a prescriber, a pharmacist, and a patient pursuant to section 2317.02 of the Revised Code.

(C) Records relating to the practice of pharmacy, the administration of drugs, or any patient specific drug transaction which may be required as evidence of a violation shall be released, upon request, to a member, inspector, agent, or investigator of the state board of pharmacy or any state, county, or municipal officer whose duty is to enforce the laws of this state or the United States relating to drugs and who is engaged in a specific investigation involving a designated person or drug. Such person shall furnish a receipt to the person having legal custody of the records. If the record is a prescription, the receipt shall list the following information:

(1) Prescription identification number; or, if an order for medication, the name of the patient;

(2) The drugs prescribed or ordered;

(3) Quantity of drugs prescribed, dispensed, administered or personally furnished;

(4) Name of the prescriber;

(5) Date, name of agency, and signature of person removing the records.

(D) All such records, including consents, memoranda of emergency disclosures, and written requests pursuant to paragraph (A)(9) of this rule, shall be kept on file at the terminal distributor of dangerous drugs for a period of three years in a readily retrievable manner.

(E) All patient records maintained by a terminal distributor of dangerous drugs shall be maintained in accordance with the following:

(1) For human patients, the Health Insurance Portability and Accountability Act of 1996 (HIPAA); and

(2) All state and federal laws, rules, and regulations.

Last updated July 1, 2024 at 5:26 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-06 Storage of adulterated drugs.

To prevent their use, adulterated drugs, as defined in agency 4729 of the Administrative Code, shall be stored in a separate and secure area apart from the storage of drugs used for dispensing, personally furnishing, compounding, and administration.

(A) Adulterated drugs shall be stored no longer than one year from the date of adulteration or expiration by those holding a terminal distributor of dangerous drugs license. Adulterated drugs shall be stored in a manner that prohibits access by unauthorized persons.

(B) Dangerous drugs, other than controlled substances, may be destroyed utilizing proper methods of disposal and following the record keeping requirements noted in agency 4729 of the Administrative Code, or may be donated to a pharmacy school pursuant to sections 3715.88 to 3715.92 of the Revised Code. Methods of disposal of non-controlled dangerous drugs shall prevent the possession or use of the drugs by unauthorized persons.

(C) Dangerous drugs that are controlled substances shall be disposed of pursuant to rule 4729:5-3-01 of the Administrative Code.

Last updated July 1, 2024 at 5:27 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-07 Controlled substances inventory requirements.

(A) Unless otherwise stated in this division of the Administrative Code, all category III terminal distributor licensees shall complete a controlled substances inventory in accordance with 21 CFR 1304.11 (9/9/2014).

(B) All controlled substance inventories performed in accordance with this rule shall be conducted on an annual basis. The annual inventory may be taken on any date which is within thirteen months of the previous inventory date.

(C) The terminal distributor's responsible person shall be responsible for completing and maintaining this inventory record at the location licensed as a terminal distributor of dangerous drugs.

(D) All inventory records shall be maintained for a period of three years from the completion date of the inventory and made readily retrievable.

(E) When a drug or compound is added to the schedule of controlled substances by state or federal law, rule or regulation, a terminal distributor shall complete an inventory pursuant to this rule of all stocks of such drug or compound no later than ten days of the drug or compound being added to the schedule.

(F) In the event a terminal distributor of dangerous drugs commences business with no controlled substances on hand, this fact shall be recorded as the initial inventory.

Last updated April 15, 2024 at 1:33 PM

History

Effective: March 1, 2019
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-08 Sales of dangerous drugs on-line.

(A) All persons selling or offering to sell dangerous drugs via the internet at retail, into, out of, or within Ohio must be properly licensed with the state board of pharmacy.

(B) All terminal distributors of dangerous drugs who sell or offer to sell dangerous drugs at retail on the internet to persons located in Ohio or any other state must make such sales only in compliance with all state and federal laws, rules, and regulations governing the legal distribution of dangerous drugs.

(C) Except as provided in paragraph (F) of this rule, all terminal distributors of dangerous drugs who sell or offer to sell dangerous drugs at retail on the internet to persons located in Ohio shall maintain a digital pharmacy accreditation from the national association of boards of pharmacy, as approved by the board.

(D) Websites owned and/or maintained by a terminal distributor of dangerous drugs who sell or offer to sell dangerous drugs at retail on the internet to persons located in Ohio or any other state must provide the following information to the public:

(1) Name under which the terminal distributor is licensed to do business as in Ohio.

(2) Full address of the licensed location.

(3) Telephone number where the terminal distributor may be contacted during regular business hours.

(4) A list of the states in which the terminal distributor may legally sell dangerous drugs.

(5) The name, address, and how the state licensing agency and the drug enforcement administration may be contacted in each state in which the person is authorized to do business. This may include a link to the agency's and the drug enforcement administration's website.

(E) Any Ohio licensed terminal distributor requesting personal information from the public by way of the internet (e.g., questionnaire forms, e-mail, etc.) must provide for security and confidentiality of the information. This portion of the website must also provide information regarding how the personal information will be used, pursuant to all federal and state laws, rules, and regulations, and ensure that such information is not used for purposes not disclosed without the written informed consent of the patient or person submitting personal information.

(F) A veterinarian, licensed under Chapter 4741. of the Revised Code, may sell or offer to sell dangerous drugs via the internet only when the internet pharmacy that fulfills the dangerous drug prescription or facilitates the sale of the dangerous drug maintains a digital pharmacy accreditation from the national association of boards of pharmacy.

Last updated July 1, 2024 at 5:27 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-09 Occasional sale and drug transfers.

(A) The term "occasional sale" as used in section 4729.51 of the Revised Code means a wholesale sale of a commercially manufactured dangerous drug that meets the definition of an exempted transaction in accordance with paragraph (J) of this rule to a drug distributor licensed in accordance with section 4729.52 of the Revised Code, terminal distributor of dangerous drugs licensed in accordance with section 4729.54 of the Revised Code, or any entity or person exempted from licensure as a terminal distributor of dangerous drugs in accordance with section 4729.541 of the Revised Code by any of the following:

(1) A pharmacy licensed as a terminal distributor of dangerous drugs.

(2) A licensed terminal distributor of dangerous drugs that is not a pharmacy, but only as authorized in section 4729.51 of the Revised Code.

(3) A local health department, as defined in paragraph (H) of this rule, licensed as a terminal distributor of dangerous drugs for the purpose of either:

(a) Improving or promoting public health within the department's jurisdiction, but only for the sale of non-controlled dangerous drugs; or

(b) Selling to another local health department licensed as a terminal distributor of dangerous drugs, but only for the sale of non-controlled dangerous drugs.

(4) A drug repository program pursuant to rule 4729:5-10-07 of the Administrative Code.

(B) The dosage units of all dangerous drugs distributed by the pharmacy pursuant to this rule shall not exceed five per cent of the total dosage units dispensed by the pharmacy during the same calendar year.

(1) A licensed terminal distributor of dangerous drugs as described in paragraph (A)(2) of this rule;

(2) Pharmacies that are also licensed to conduct sales of dangerous drugs in accordance with section 4729.52 of the Revised Code; and

(3) Drug repository programs pursuant to rule 4729:5-10-07 of the Administrative Code.

(D) The requirements of this rule do not apply to the transfer of dangerous drugs pursuant to paragraph (E) of this rule.

(E) A licensed terminal distributor of dangerous drugs having more than one licensed location may transfer or deliver dangerous drugs from one licensed location to another licensed location owned by that terminal distributor if the license issued for each location is in effect at the time of the transfer or delivery. Such transfer or delivery includes either of the following:

(1) Intracompany sales, which includes any transaction or transfer between any division, subsidiary, parent or affiliated or related company under the common ownership and control.

(2) The sale, purchase, or transfer of a drug or an offer to sell, purchase, or transfer of a drug among hospitals or other health care entities that are under common control. Common control means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise.

(F) Occasional sales by a licensed terminal distributor shall comply with the reporting requirements set forth in division 4729:8 of the Administrative Code.

(G) "Drug shortage," with respect to an occasional sale, means a drug on the United States food and drug administration's drug shortage list that is not commercially available regardless of the reason that the drug is not available, including the absence of a manufacturer for the drug or the lack of a readily available supply of the drug from a manufacturer or wholesaler.

(H) "Local health department' means a department operated by a board of health of a city or general health district or the authority having the duties of a board of health as described in section 3709.05 of the Revised Code.

(I) "Dosage unit" means any of the following:

(1) A single pill, capsule, ampule, or tablet;

(2) In the case of a liquid solution, one milliliter;

(3) In the case of a cream, lotion or gel, one gram; or

(4) Any other form of administration available as a single unit.

(J) "Exempted transaction" includes all the exemptions to the definition of a transaction pursuant to 21 U.S. Code section 360eee (11/27/2013).

Last updated May 1, 2025 at 7:55 AM

History

Effective: May 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-10 Employment of individuals with felony convictions.

(A) Pursuant to 21 C.F.R. 1301.76 (6/22/2023), a terminal distributor of dangerous drugs that is a United States drug enforcement administration registrant shall not employ in a position which allows access to controlled substances any person who has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for drug enforcement administration registration denied, revoked, or surrendered for cause.

"For cause" means surrendering a registration in lieu of, or as a consequence of, any federal or state administrative, civil, or criminal action resulting from an investigation of the individual's handling of controlled substances.

(B) Paragraph (A) of this rule does not apply if a waiver is obtained by a licensee pursuant to 21 C.F.R. 1307.03 (3/9/2010).

Last updated July 1, 2024 at 5:28 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-11 Transmission of outpatient prescriptions.

(A) Oral transmission by a prescriber or a prescriber's agent of an original outpatient prescription authorized by a prescriber shall comply with the requirements of rule 4729:5-5-15 of the Administrative Code. For any oral outpatient prescription transmitted by an agent of a prescriber, the prescriber's agent must provide the agent's first and last name when transmitting the prescription. An oral prescription may be transmitted by a prescriber or prescriber's agent to a recording device or voice mail service.

(B) Original written outpatient prescriptions shall be authorized and signed by a prescriber, in the same manner as the prescriber would sign a check or legal document, and may be transmitted by the prescriber or the prescriber's agent by facsimile machine to a pharmacy.

(1) The facsimile of the prescription must include the identification number of the facsimile machine which is used to transmit the prescription, the full name of the prescriber and, if applicable, the full name of the prescriber's agent transmitting the prescription to the pharmacy.

(2) The prescription must comply with the requirements of rule 4729:5-5-15 of the Administrative Code.

(3) The original prescription signed by the prescriber from which the facsimile is produced shall not be issued to the patient. The original prescription signed by the prescriber must remain with the patient's records at the location where it was issued for three years from the date of issuance. Following the successful transmission of the prescription, the word "VOID" or "FAXED" shall be written or stamped on the face of the original prescription in a manner that does not destroy any of the original information contained on the prescription.

(4) Outpatient prescriptions for schedule II controlled substances may be transmitted by facsimile in accordance with 21 C.F.R. 1306.11 (5/1/2019) and shall meet the facsimile requirements of this rule.

(C) Outpatient prescriptions may be transmitted by means of an electronic prescription transmission system that complies with the prescription requirements in rule 4729:5-5-15 of the Administrative Code.

(1) An outpatient prescription transmitted by means of an electronic prescription transmission system shall include the full name of the prescriber's agent transmitting the prescription.

(2) A controlled substance outpatient prescription shall only be transmitted by means of an electronic prescription transmission system if the system complies with 21 CFR 1311 (5/1/2019).

(3) Except as provided in paragraphs (C)(4) and (C)(5) of this rule, no prescriptions may be transmitted by means of an electronic prescription transmission system that converts the prescription into a computer-generated fax or scanned image.

(4) A non-controlled prescription may be transmitted by means of an electronic prescription transmission system that converts the prescription into a computer-generated fax or scanned image if all the following apply:

(a) The transmission is conducted by means of a board approved system that meets the prescription requirements of rule 4729:5-5-15 of the Administrative Code.

(b) The prescription transmission system operates within a closed-system. A closed system includes any system whereby prescription information is transmitted directly between:

(i) Any division, subsidiary, parent or affiliated or related company under common ownership and control; or

(ii) One or more contracted entities. Contracted means having a written agreement (to include business associate agreements) between one or more prescribers and a pharmacy and shall not include a third-party intermediary unless otherwise approved by the board.

(5) A non-controlled prescription may be converted into a computer-generated fax by a board approved third-party intermediary only if the conversion is necessitated by a temporary telecommunication outage of the third-party intermediary or receiving pharmacy.

Last updated July 1, 2026 at 3:09 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-12 Protocols and pre-printed orders for medication administration.

(A) A terminal distributor of dangerous drugs may distribute or dispense dangerous drugs pursuant to a protocol. As used in this rule, "protocol" means a definitive set of written treatment guidelines with orders for drugs and their specified dosages for administration to individuals under the following circumstances:

(1) The provision of medical services to individuals in an emergency situation when the services of a prescriber authorized by the revised code to prescribe dangerous drugs as part of their professional practice are not immediately available. An emergency situation may manifest itself by acute symptoms of sufficient severity that an authorized individual providing medical services under this paragraph could reasonably expect the absence of immediate medical attention to result in placing the health of the individual or, with respect to a pregnant woman, the health of the woman or her unborn child, in serious jeopardy; serious impairment to bodily functions; or serious dysfunction of any bodily organ or part. Examples of emergency situations includes cases such as heart attacks, severe burns, extravasation, overdoses, cyanide poisonings, electrocutions, or severe asthmatic attacks;

(2) The administration of biologicals or vaccines to individuals for the purpose of preventing diseases;

(3) The administration of vitamin K for prevention of vitamin K deficient bleeding in newborns;

(4) The administration of erythromycin for prevention of ophthalmia neonatorum; and

(5) The administration of influenza antiviral treatment and chemoprophylaxis to residents and health care personnel at an institutional facility, as defined in agency 4729 of the Administrative Code, according to current guidance issued by the United States center for disease control and prevention.

(B) A protocol described in paragraph (A) of this rule shall:

(1) Include a description of the intended recipients to whom the drugs are to be administered; drug name and strength; instructions of how to administer the drug, dosage, and frequency; signature of a prescriber or some other form of positive identification of the prescriber as defined in agency 4729 of the Administrative Code; and date of signature;

(2) Be administered by an individual authorized by law to administer the drugs;

(3) Be made readily retrievable;

(4) Be reviewed as necessary to ensure patient safety and practice in accordance with acceptable and prevailing standards of care; and

(5) Be maintained by the terminal distributor of dangerous drugs for a period of three years from the date of authorization or reauthorization following any modification or amendment.

(C) A terminal distributor of dangerous drugs may distribute or dispense dangerous drugs for administration pursuant to a pre-printed order. As used in this rule, "pre-printed order" means a patient specific and dose specific order for the administration of a specific drug or drugs prescribed by a licensed health care professional authorized to prescribe drugs. The prescriber must complete an assessment and make a diagnosis prior to initiating a pre-printed order in accordance with the prescriber's scope of practice. The pre-printed order may only be initiated upon the order of a prescriber authorized by law to prescribe the drugs listed in the pre-printed orders. The drugs shall be administered by an individual authorized by law to administer the drugs.

(D) A pre-printed order described in paragraph (C) of this rule shall:

(1) Include the name of the patient; drug name and strength; specific instructions of how to administer the drug, dosage, and frequency; instructions of any patient specified dosage range based on objective measures such as calculations and patient physiologic data; signature of the prescriber or some other form of positive identification of the prescriber as defined in agency 4729 of the Administrative Code; and date of signature;

(2) Apply only to those drugs for which the therapeutic dose is significantly lower than the dose expected to cause detrimental adverse effects;

(3) Can be performed without requiring the exercise of medical judgment;

(4) Will lead to results that are reasonably predictable and safe;

(5) Can be performed safely by the individual authorized to administer the drugs and without the need for repeated medical assessments;

(6) Be maintained by the terminal distributor of dangerous drugs for a period of three years from the date of initiation. A pre-printed order which becomes a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph;

(7) Be made readily retrievable;

(8) If performed improperly, would not present a danger of immediate and serious harm to the patient; and

(9) Be reviewed as necessary to ensure patient safety and practice in accordance with acceptable and prevailing standards of care.

(E) Nothing in this rule shall be construed to otherwise prohibit the dispensing or administration of dangerous drugs pursuant to a protocol that is specifically authorized in the Revised Code or agency 4729 of the Administrative Code.

(F) For purposes of this rule, a terminal distributor of dangerous drugs may distribute or dispense dangerous drugs for administration to animals pursuant to a protocol in accordance with the provisions of paragraphs (A) and (B) of this rule or a pre-printed order in accordance with the provisions of paragraphs (C) and (D) of this rule.

Last updated May 19, 2026 at 4:58 PM

History

Effective: March 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-13 Temporary removal of dangerous drugs from a licensed location.

No licensed terminal distributor of dangerous drugs shall engage in the sale or other distribution of dangerous drugs at retail or maintain possession, custody, or control of dangerous drugs for any purpose at any establishment or place other than that or those described in the license issued by the state board of pharmacy to such terminal distributor, except as follows:

(A) A licensed health professional authorized to prescribe drugs may temporarily remove dangerous drugs from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients. The dangerous drugs shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The licensed health professional shall maintain direct supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. The responsible person on the terminal distributor of dangerous drugs license shall be responsible for compliance with the requirements of this paragraph.

(B) A person authorized to personally furnish or dispense naloxone in accordance with a physician approved protocol. The naloxone shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The authorized person shall maintain direct supervision and control over the naloxone removed from the terminal distributor. If direct supervision is not provided, the naloxone shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. The responsible person on the terminal distributor of dangerous drugs license shall be responsible for compliance with the requirements of this paragraph.

(C) A licensed health care professional, in accordance with their applicable scope of practice, who provides immunizations or any other non-controlled substance dangerous drugs that may be administered in accordance with a protocol or valid prescriber's order may temporarily remove dangerous drugs from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients. The dangerous drugs shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The licensed health professional shall maintain direct supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. The responsible person on the terminal distributor of dangerous drugs license shall be responsible for compliance with the requirements of this paragraph.

(D) An emergency medical service (EMS) organization providing emergency medical services and in accordance with Chapter 4729:5-14 of the Administrative Code.

(E) A veterinarian licensed pursuant to Chapter 4741. of the Revised Code may maintain a supply of dangerous drugs obtained from a licensed terminal distributor of dangerous drugs at another location in order to treat current or prospective patients. A veterinarian shall maintain direct supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and all reasonable efforts shall be made to store the drugs at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Any drugs maintained pursuant to this paragraph are subject to inspection by a board of pharmacy agent and shall be subject to all recordkeeping, labeling, theft or significant loss reporting, disposal, and inventory requirements of division 4729:5 of the Administrative Code. Records shall be maintained by the terminal distributor of dangerous drugs in accordance with Chapter 4729:5-20 of the Administrative Code. The responsible person on the terminal distributor of dangerous drugs license from which the drugs are obtained shall be responsible for compliance with the requirements of this paragraph. A veterinarian maintaining dangerous drugs in accordance with this rule shall only obtain the drugs from single terminal distributor and shall not co-mingle drug stock from another terminal distributor of dangerous drugs. The terminal distributor of dangerous drugs shall also maintain the following records for controlled substance dangerous drugs removed from the terminal distributor of dangerous drugs that are stored off-site for more than twenty-four hours: name, strength, dosage form, and quantity of the controlled substance dangerous drugs, the positive identification of the veterinarian who removed the drugs, and the address of the location where the drugs are maintained. Corresponding records shall also be maintained for any controlled substances returned to the terminal distributor's inventory of dangerous drugs from the off-site location. All records required in accordance with this paragraph shall be readily retrievable and maintained for at least three years from the date of removal or return. Failure by a veterinarian to exercise supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code or adequate safeguards as required in division (C) of section 4729.55 of the Revised Code shall be deemed a violation of this rule.

(F) A person licensed or certified under Chapter 4765. of the Revised Code may maintain a supply of medical oxygen and/or naloxone obtained from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients in the event of an emergency. The medical oxygen and/or naloxone shall be maintained for an amount of time as determined by written authorization from the licensee's medical director. Medical oxygen and naloxone shall only be administered in accordance with the licensee's protocol or valid prescriber order. The individuals authorized by to this paragraph shall maintain personal supervision and control over the medical oxygen and/or naloxone removed from the terminal distributor. If personal supervision is not provided, the medical oxygen and/or naloxone shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions which will ensure the integrity of the medical oxygen and/or naloxone prior to its use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(G) A certified officer, as defined in section 4729.533 of the Revised Code, may maintain a supply of dangerous drugs, as authorized in rule 4729:5-15-05 of the Administrative Code, obtained from a licensed terminal distributor of dangerous drugs with a chemical capture classification at another location in order to engage in chemical capture. A certified officer shall maintain direct supervision and control over the dangerous drugs, equipment, and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs, equipment, and any hypodermics shall be physically secured in a manner to prevent unauthorized access and all reasonable efforts shall be made to store the drugs at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Any drugs maintained pursuant to this paragraph are subject to inspection by a board of pharmacy agent and shall be subject to all recordkeeping, labeling, theft or significant loss reporting, disposal, and inventory requirements of division 4729:5 of the Administrative Code. Records shall be maintained by the terminal distributor of dangerous drugs in accordance with Chapter 4729:5-15 of the Administrative Code. The responsible person on the terminal distributor of dangerous drugs license from which the drugs are obtained shall be responsible for compliance with the requirements of this paragraph. A certified officer maintaining dangerous drugs in accordance with this rule shall only obtain the drugs from single terminal distributor and shall not co-mingle drug stock from another terminal distributor of dangerous drugs. The terminal distributor of dangerous drugs shall also maintain the following records for controlled substance dangerous drugs removed from the terminal distributor of dangerous drugs that are stored off-site: name, strength, dosage form, and quantity of the controlled substance dangerous drugs, the positive identification of the certified officer who removed the drugs, and the address of the location where the drugs are maintained. Corresponding records shall also be maintained for any controlled substances returned to the terminal distributor's inventory of dangerous drugs from the off-site location. All records required in accordance with this paragraph shall be readily retrievable and maintained for at least three years from the date of removal or return. Failure by a certified officer to exercise supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code or adequate safeguards as required in division (C) of section 4729.55 of the Revised Code shall be deemed a violation of this rule.

(H) An opioid treatment program operating a mobile opioid treatment program in accordance with rule 4729:5-21-05 of the Administrative Code.

(I) As used in this rule, "direct supervision" means an individual authorized pursuant to this rule is in the immediate area and within visual range of dangerous drugs and/or hypodermics to deter and detect diversion.

Last updated May 19, 2026 at 4:58 PM

History

Effective: December 26, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-14 General security requirements.

(A) All terminal distributors of dangerous drugs shall provide effective controls and procedures to:

(1) Deter and detect the theft and diversion of dangerous drugs; and

(2) Ensure supervision and control of dangerous drugs, as required in division (B) of section 4729.55 of the Revised Code, and adequate safeguards to ensure that dangerous drugs are being distributed in accordance with all state and federal laws, as required in section 4729.55 of the Revised Code.

(B) Substantial compliance with the standards set forth in this division of the Administrative Code may be deemed sufficient by the state board of pharmacy after evaluation of the overall security system and needs of the licensee or applicant. In evaluating the overall security system of a licensee or applicant, the state board of pharmacy may consider any of the following factors, as deemed relevant, for compliance with security requirements:

(1) The type of activity conducted;

(2) Type and form of dangerous drugs handled;

(3) Quantity of dangerous drugs handled;

(4) Location of the premises and the relationship such location bears on security needs;

(5) Type of building construction comprising the facility and the general characteristics of the building or buildings;

(6) Type of vaults, safes, and secure enclosures or other storage system (e.g. automatic storage and retrieval system) used;

(7) Type of closures on vaults, safes, and secure enclosures;

(8) Adequacy of key control systems and/or combination lock control systems;

(9) Adequacy of electronic detection and alarm systems, if any, including use of supervised transmittal lines and standby power sources;

(10) Extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;

(11) Adequacy of supervision over authorized employees having access to areas containing dangerous drugs;

(12) Procedures for handling business guests, visitors, maintenance personnel, and non-employee service personnel; and

(13) Adequacy of the licensee's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of dangerous drugs in its operation.

(C) When physical security controls become inadequate as a result of a significant increase in the quantity of dangerous drugs in the possession of the licensee during normal business operation, the physical security controls shall be expanded and extended accordingly.

(D) Any applicant seeking to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in this division of the Administrative Code may submit any plans, blueprints, sketches, or other materials regarding the proposed security system to the state board of pharmacy.

Last updated May 19, 2026 at 4:58 PM

History

Effective: March 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-15 Use of hospital and other institution D.E.A. registrations.

(A) As used in this rule, "hospital or other institution" has the same meaning as in Part 1301 of the Code of Federal Regulations.

(B) A prescriber who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employment, administer, personally furnish, or prescribe controlled substances under the "Drug Enforcement Administration" (D.E.A.) registration of the hospital.

(C) A person pursuing an approved training program within the jurisdiction of the hospital or other institution and authorized to write prescriptions pursuant to paragraph (B) of rule 4729:5-1-02 of the Administrative Code may administer, personally furnish, or prescribe controlled substances under the registration of the hospital or other institution. Persons pursuing such approved training programs may function in sites outside the physical confines of the hospital or other institution only if such sites are part of the training program and the persons are under the employment and jurisdiction of the hospital or other institution administering the approved program. While functioning in the outside sites, such persons may continue to use the internal code assigned by the hospital or other institution administering the approved program, upon mutual agreement of the hospital or other institution and the outside site.

(D) The administering, personally furnishing, or prescribing must be done in the usual course of the person's professional practice and only within the scope of the person's employment in the hospital or other institution.

(E) Each person so authorized must be assigned a specific internal code number by the hospital or other institution which will be used as a suffix to the hospital D.E.A. registration number. Such internal code number shall consist of numbers, letters, or a combination thereof, shall be preceded by a hyphen, and no more than ten characters in length, excluding the hyphen. A current list of the internal codes and the corresponding individual prescribers must be kept by the hospital or other institution and made available at all times to other registrants, state board of pharmacy designated agents, investigators of the state medical board, and federal, state, county, or municipal law enforcement agencies for verification.

A current list of internal codes and the corresponding individual prescribers shall be filed with the state board of pharmacy, in a manner and format determined by the board. Additions, deletions or changes to the list must be submitted to the state board of pharmacy within ten business days of any such addition, deletion or change.

(F) A pharmacist practicing under a consult agreement, as authorized in section 4729.39 of the Revised Code, shall not prescribe controlled substances under the registration of the hospital or other institution.

Last updated May 19, 2026 at 4:58 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-16 Returned drugs.

(A) No drug that has been dispensed pursuant to a prescription or personally furnished by a prescriber and has left the physical premises of the terminal distributor of dangerous drugs shall be returned to the terminal distributor or dispensed or personally furnished again, except as follows:

(1) Drugs dispensed for inpatients, as defined in agency 4729 of the Administrative Code, or personally furnished to inpatients provided that:

(a) The drugs are packaged in unopened, single-dose or tamper-evident containers; and

(b) The drugs have not been in the possession of the ultimate user.

(2) Drugs dispensed for inpatients, as defined in agency 4729 of the Administrative Code, in accordance with rule 4729:5-9-02.11 of the Administrative Code.

(3) Drugs dispensed for outpatients in accordance with rules 4729:5-5-22 and 4729:5-5-18 of the Administrative Code.

(4) Drugs dispensed for patients, which have not been dispensed or personally furnished directly to the ultimate user, that require further manipulation prior to administration.

(5) Drugs donated to a drug repository program in accordance with Chapter 4729:5-10 of the Administrative Code.

(6) Drugs returned for destruction or disposal in accordance with division 4729:10 of the Administrative Code and rule 4729:5-5-14 of the Administrative Code.

(7) Hazardous drugs for destruction or disposal in accordance with all applicable federal, state, and local laws, rules, and regulations.

(B) As used in this rule, "hazardous drug" means any drug listed on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code.

(C) Except as provided in section 4729.43 of the Revised Code, nothing in this rule prohibits a terminal distributor of dangerous drugs from administering a dangerous drug that was dispensed or personally furnished directly to a patient or patient's caregiver.

Last updated June 11, 2026 at 11:14 AM

History

Effective: March 9, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-17 Automated pharmacy systems.

(A) As used in this rule:

(1) "Automated pharmacy system" means a mechanical system that performs operations or activities, other than administration, relative to storage, packaging, compounding, dispensing, or distribution of dangerous drugs that collects, controls, and maintains transaction information and records.

"Automated pharmacy system" does not include an "automated drug storage system" utilized by institutional facilities pursuant to Chapter 4729:5-9 of the Administrative Code or other locations licensed as terminal distributors of dangerous drugs.

(2) "Dispense" means the final association of a drug with a particular patient pursuant to a prescription, drug order, or other lawful order of a prescriber and the professional judgment of and the responsibility for interpreting, preparing, compounding, labeling, and packaging a specific drug.

(a) In the case of an automated pharmacy system that dispenses dangerous drugs without the final association by a pharmacist, the system shall capture the positive identification of the pharmacist authorizing the patient specific prescription in the system prior to its dispensation.

(b) Nothing in this paragraph shall prohibit an automated pharmacy system from being utilized to restock an automated drug storage system utilized by institutional facilities pursuant to Chapter 4729:5-9 of the Administrative Code or other locations licensed as terminal distributors of dangerous drugs.

(3) "Positive identification" has the same meaning as in rule 4729:5-5-01 of the Administrative Code.

(4) "Tamper evident" means a package, storage container or other physical barrier that is sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

(B) An automated pharmacy system shall be approved by the board prior to its implementation by the terminal distributor of dangerous drugs.

(1) Prior to the approval of an automated pharmacy system, the board shall receive a request from the responsible person on the terminal distributor of dangerous drugs license. Upon notification, the board shall conduct an inspection of the system to determine if it meets the requirements of this rule.

(2) For automated pharmacy systems that dispense dangerous drugs in accordance with paragraph (A)(2)(a) of this rule, the responsible person of the licensed terminal distributor of dangerous drugs shall be required to have a pharmacist verify for accuracy all dangerous drugs dispensed by the system for a continuous forty-five-day period. The responsible person shall compile metrics, using a form developed by the board, documenting the performance of the system during this period. Unless otherwise approved by the board, the accuracy metrics during the forty-five day pharmacy review period shall be no less than ninety-nine and nine hundred eighty-five thousandths (99.985) per cent.

(3) Approval of all automated pharmacy systems shall be site-specific.

(D) A terminal distributor of dangerous drugs operating an automated pharmacy system shall maintain the following documentation on-site in a readily retrievable manner:

(1) The manufacturer's name and model;

(2) A description of how the automated pharmacy system is used; and

(3) Policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access, and malfunction.

(E) All records maintained in accordance with this rule, including documentation of quality assurance metrics, shall be readily retrievable and maintained for period of three years.

(F) For automated pharmacy systems that dispense dangerous drugs in accordance with paragraph (A)(2)(a) of this rule, the terminal distributor of dangerous drugs shall implement a quality assurance program to determine continued appropriate use of the automated pharmacy system. The quality assurance program shall monitor the performance of the automated pharmacy system, ensure the system is in good working order and accurately prepares the correct strength, dosage form, and quantity of the drug prescribed or ordered. At a minimum, the quality assurance program shall consist of a review of at least five per cent of all dispensed prescriptions over the daily operational hours of the automated pharmacy system.

(G) If an automated pharmacy system that dispenses dangerous drugs in accordance with paragraph (A)(2)(a) of this rule selects an incorrect drug, the terminal distributor shall immediately institute a one hundred per cent pharmacist verification of all drugs dispensed. The one hundred per cent verification procedure shall continue until such time as the terminal distributor can document that the cause of the error has been determined and addressed and that the system is no longer making errors.

(H) A registered or certified pharmacy technician, pharmacy technician trainee, pharmacy intern, or nurse licensed in accordance with Chapter 4723. of the Revised Code may stock an automated pharmacy system provided that:

(1) Except as provided in paragraph (H)(2) of this rule, the container, canister, or other dangerous drug storage device being stocked by the technician, trainee, intern, or nurse is tamper-evident and is verified by a pharmacist and documented using positive identification.

(2) Pharmacist verification requirements in paragraph (H)(1) of this rule do not apply if all the following are met:

(a) Verification is being conducted by a registered or certified pharmacy technician, pharmacy intern, or nurse; and

(b) The container, canister, or other dangerous drug storage device being stocked is properly identified by bar code or other such secondary information system, which has been verified by a pharmacist to ensure the proper drug is being placed into and recognized as the correct drug by the system.

(3) The utilization of a bar code, electronic verification, or similar verification process shall require an initial quality assurance validation by a pharmacist and shall be followed by a quarterly quality assurance review by a pharmacist.

(4) The positive identification of the individual stocking the system is documented.

(5) A pharmacist is fully responsible for all activities conducted by the technician, trainee, intern, or nurse.

(6) A pharmacist must be immediately available to answer questions or discuss the stocking of an automated pharmacy system.

(7) A registered pharmacy technician or pharmacy technician trainee shall be acting under the personal supervision of a pharmacist.

(I) Except for an automated pharmacy system in a long-term care facility, a pharmacist shall be physically present at the terminal distributor of dangerous drugs to provide supervision of the automated pharmacy system.

(J) The automated pharmacy system shall have security to prevent unauthorized individuals from accessing or obtaining dangerous drugs and include safeguards to detect the diversion of dangerous drugs. This shall include the use of tamper-evident containers, canisters, or other storage devices for use in long-term care facilities.

(K) The records kept by the automated pharmacy system shall comply with the applicable record keeping requirements of division 4729:5 of the Administrative Code and shall also capture all events involving the contents of the automated pharmacy system.

(L) If applicable, an automated pharmacy system shall comply with the requirements set forth in 21 CFR 1301.27 (5/13/2005) for automated systems in long term care facilities.

Last updated June 4, 2021 at 8:24 AM

History

Effective: June 4, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-18 Dangerous drug recall procedures.

(A) A terminal distributor of dangerous drugs shall develop and implement a written procedure for the management of recalls by the manufacturer for dangerous drugs stocked by the terminal distributor. Such procedures shall include, where appropriate, contacting patients to whom the recalled drug products have been dispensed or personally furnished.

(B) The written procedure shall include, but not be limited to, the following:

(1) The terminal distributor shall make a reasonable attempt to ensure that a recalled drug has been removed from inventory no later than the next business day after receipt of the recall notice by the responsible person or the responsible person's designee, and quarantined until proper disposal, destruction, or return of the drug;

(2) If the drug that is the subject to a recall is maintained by the terminal distributor in a container without a lot number, the terminal distributor shall consider this drug included in the recall; and

(3) Maintaining records for activities taken by the terminal distributor in relation to a drug recall.

(C) The written procedures shall be updated as necessary and maintained in a readily retrievable manner. All records documenting recall activities shall be maintained for three years and shall be made readily retrievable.

Last updated November 12, 2024 at 8:39 AM

History

Effective: November 11, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-20 Pharmacy pilot or research projects.

(A) The purpose of this rule is to specify the process and procedures to be followed when a licensee petitions for approval of a pilot or research project for innovative system applications in the practice of pharmacy that are not currently permitted under agency 4729 of the Administrative Code. In reviewing projects, the board shall consider only projects that expand pharmaceutical care services that contribute to positive patient outcomes.

(B) A project shall not expand the definition of the practice of pharmacy as set forth in Chapter 4729. of the Revised Code and shall not apply to licensees regulated under Chapter 3796. of the Revised Code.

(C) Approval of a project by the board may include the grant of a limited exception to or a waiver of rules adopted under Chapter 4729. of the Revised Code. Project approval, including limited exception to or waiver of board rules, shall initially be for a specified period of time not exceeding twenty-four months from commencement of the project.

(D) Following the completion of the project period, the board may do any of the following based upon a review of the final project report submitted in accordance with paragraph (I) of this rule and any other factors or information the board deems necessary:

(1) Refuse to extend or renew the project;

(2) Approve the extension or renewal of a project following consideration of a petition that clearly identifies the need for extension and must include a report similar to the final project report, which should describe and explain any proposed changes to the originally approved and implemented project, and that justifies the need for extending or renewing the term of the project; or

(3) Approve the project in perpetuity following a consideration of a petition that clearly identifies and justifies the need to continue the project indefinitely.

(E) A licensee who wishes the board to consider approval of a project shall submit to the board a petition for approval that contains at least the following information:

(1) Responsible pharmacist. Name, address, telephone number, and pharmacist license number of each pharmacist responsible for overseeing the project.

(2) Location of project. Name, address, and telephone number of each specific location and, if a location is a pharmacy, the pharmacy's terminal distributor of dangerous drugs license number where the proposed project will be conducted.

(3) Project summary. A detailed summary of the proposed project that includes at least the following information:

(a) The goals, hypothesis, and objectives of the proposed project.

(b) A full explanation of the project and how it will be conducted.

(c) The time frame for the project including the proposed start date and length of the project. The time frame may not exceed eighteen months from the proposed start date of the project.

(d) Background information or literature review to support the proposed project.

(e) The rule or rules to be waived in order to implement the project, an explanation of why such a waiver would not be a detriment to the public, to include procedures to be used during the project to ensure that the public health and safety are not compromised as a result of the waiver, and a request to waive the rule or rules.

(F) Projects submitted shall be reviewed as follows:

(1) Staff review. Upon receipt of a petition for approval of a project, board staff shall initially review the petition. If the petition is incomplete or fails to meet the board's outlined purpose, staff shall return the petition to the requestor with a letter explaining the reason the petition is being returned. A petition that has been returned pursuant to this paragraph may be amended or supplemented as necessary and submitted for reconsideration. A petition that is deemed appropriate and complete shall move on the board member review process.

(2) Board member review. After initial staff review, two members of the board, appointed by the board president, shall be provided the petition and any additional materials. Board members shall conduct a review, in consultation with appropriate staff, and make a recommendation to the full board. Board members conducting a review may request additional documentation and information from the petitioner as part of this review process.

(3) Board review. Following the board member review, the board shall consider the project request at a regularly scheduled meeting of the board. Upon review, the board shall either approve or deny the petition. The board shall not approve any such project if such proposal might jeopardize public health or welfare. If the board approves the petition, the approval:

(a) Shall be specific for the project requested, with any modifications the Board deems necessary for patient safety;

(b) Shall approve the project for a specific time period; and

(c) May include conditions or qualifications applicable to the project, including limited waivers of applicable/related rules.

(G) The project site and project documentation shall be available for inspection and review by the board or its representative(s) at any time during the approval or denial processes and, if a project is approved, throughout the approved term of the project.

(H) Project documentation shall be maintained in a readily retrievable manner and available for inspection, review, and copying by the board or its representative for at least three years following completion or termination of the project.

(I) The pharmacist responsible for overseeing a project shall be responsible for submitting to the board any reports required as a condition of a project, including the final project report.

(1) The final project report shall include a written summary of the results of the project and the conclusions drawn from those results. The final project report shall be submitted to the board within ninety days after completion or termination of the project.

(2) The board shall review any required report regarding the progress of a project and the final project report at a regularly scheduled meeting of the board.

(J) The board may rescind approval and terminate projects, including those it has approved in perpetuity, pursuant to the following:

(1) If the board deems the project does not the comply with the requirements of this rule or the conditions of its approval, the board shall provide notice to the pharmacist responsible for the project indicating the project's approval has been rescinded. The notice shall provide sixty days for the pharmacist to address any deficiencies prior to the termination of the project. If the deficiencies cited in the notice are addressed, the board may reinstate the project prior to its proposed termination date.

(2) If the board has reasonable cause to believe the project poses a threat of immediate or serious harm to the public, the board shall provide notice to the pharmacist responsible for the project indicating the project's approval has been rescinded. The termination of the project shall take effect immediately.

(K) The petitioner and/or project's responsible person may terminate the project earlier than requested but shall provide notice within three business days of termination and a final project report to the board to include an explanation of why the project was terminated early. Upon either recission of approval or early project termination, any waivers granted will be immediately revoked and the licensee will be required to adhere to those rules that had been excepted or waived.

(L) All documents pertaining to the application, project, and reports are considered a public record under section 149.43 of the Revised Code and will be provided upon request, without notice to the project's petitioners and/or responsible person. Petitioners asserting that some or all of an application contains information exempt from disclosure under Ohio law shall comply with the following:

(1) Submit a memorandum identifying the content not subject to disclosure under section 149.43 of the Revised Code, including supporting legal authority for each assertion.

(2) Submit a redacted version of the materials that the applicant agrees may be released without prior notice to the applicant.

(M) By submitting the application, the petitioner understands, acknowledges, and agrees to all of the following:

(1) The board may independently assess the merits of any public records exception claims made by the petitioner.

(2) The board may reject a claim that information in an application is trade secret or a security or infrastructure record if it determines that the petitioner has not established that the content in question meets a delineated exception to public disclosure under Ohio law, including the use of generic language encompassing substantial portions of the application submission or simple assertions of a document containing information exempt from public disclosure, without substantive explanation of the basis.

(3) The state of Ohio does not assume liability for the use or disclosure of any unredacted material.

(4) The board is required to comply with section 149.43 of the Revised Code, which is construed liberally in favor of broad access, and any doubt shall be resolved in favor of disclosure of public records.

(N) The board will make reasonable efforts to determine the initial approval or denial of a project submission within ninety days of the submission of a completed project petition in accordance with paragraph (E) of this rule.

The board shall be required to make the initial approval or denial of a project submission within one hundred and eighty days of the submission of a completed project petition in accordance with paragraph (E) of this rule. This timeframe may be extended by the board for good cause.

(O) Unless otherwise approved by the board, a petition shall be deemed abandoned if the petitioner fails to submit any requested documentation or information within thirty days after being notified by the board. The board shall not be required to act on any abandoned petition and the petition may be destroyed by board staff. If the petition is abandoned, the petitioner shall be required to resubmit a new petition for consideration pursuant to the requirements of this rule.

Last updated September 11, 2023 at 11:43 AM

History

Effective: March 11, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-21 Point of dispensing locations during a public health emergency.

(A) A board of health, as defined in section 3701.048 of the Revised Code, that is licensed as a terminal distributor of dangerous drugs may temporarily remove dangerous drugs upon the governor's declaration of an emergency that affects the public health.

(B) The dangerous drugs removed from a location licensed as a terminal distributor shall be used to establish a point of dispensing location or locations in the event of a declared public health emergency to administer, deliver, dispense, or distribute drugs in accordance with protocols developed pursuant to section 3701.048 of the Revised Code.

(C) The dangerous drugs shall be returned to the board of health within seventy-two hours of the cessation of the public health emergency. An individual listed in divisions (B) and (C) of section 3701.048 of the Revised Code shall maintain personal supervision and control over the dangerous drugs removed from the terminal distributor.

(D) If personal supervision is not provided, the dangerous drugs shall be physically secured in a manner to prevent unauthorized access and diversion. The drugs shall be stored at temperatures which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(E) All point of dispensing sites established in accordance with this rule shall cease to operate upon the cessation of the public health emergency but may be extended at the request of the director of health.

(F) The board's executive director, upon consultation with the board president, may grant variances or extensions to the requirements set forth in this rule if it is determined that such a variance is in the public interest.

Last updated October 6, 2023 at 8:42 AM

History

Effective: October 6, 2023
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-22 Continuous quality improvement programs in pharmacy services.

(A) As used in this rule, "dispensing error" or "error in dispensing" means one or more of the following discovered after the dispensation (e.g., final verification) by a pharmacist or verification in accordance with rule 4729:5-3-17 of the Administrative Code, regardless of whether the patient received the drug:

(1) Variation from the prescriber's prescription or drug order, unless otherwise modified by the pharmacist in accordance with agency 4729 of the Administrative Code, including:

(a) Incorrect drug;

(b) Incorrect drug strength;

(d) Incorrect patient; or

(e) Inadequate or incorrect packaging, labeling, or directions.

(2) Failure to exercise professional judgment in identifying and managing:

(a) Known therapeutic duplication;

(b) Known drug-disease contraindications;

(d) Incorrect drug dosage or duration of drug treatment;

(e) Known drug-allergy interactions;

(f) Any product quality issue attributed to a compounded drug preparation;

(g) A clinically significant, avoidable delay in therapy; or

(h) Any other significant, actual, or potential problem with a patient's drug therapy related to the practice of pharmacy.

(3) Sale of a drug to the incorrect patient.

(4) Variation in bulk repackaging or filling of automated devices, including:

(a) Incorrect drug;

(b) Incorrect drug strength;

(d) Inadequate or incorrect packaging or labeling.

(5) A dispensing error does not include the delivery of an incorrect drug to a patient by a pharmacy delivery agent as defined in rule 4729:5-5-22 of the Administrative Code.

(B) A "dispensing error" or "error in dispensing," as defined in paragraph (A) of this rule, may be considered a violation of division (A)(2) of section 3715.52 and section 3715.64 of the Revised Code.

(C) Each pharmacy licensed as a terminal distributor of dangerous drugs shall establish or participate in an established quality assurance program that documents and assesses dispensing errors to determine cause and an appropriate response to improve the quality of pharmacy service and prevent errors.

(1) Each quality assurance program shall be managed in accordance with written policies and procedures maintained in the pharmacy to be made readily retrievable upon request of an agent, inspector, or employee of the board.

(2) The quality assurance program shall include necessary documentation, internal reporting, and assessment of dispensing errors to determine the cause and an appropriate response to prevent future dispensing errors.

(3) All records of the quality assurance program for each pharmacy shall be maintained for three years from the date of creation in a readily retrievable manner.

(4) Any record reviewed in accordance with this paragraph shall be for investigation or inspection purposes and shall be subject to confidentiality protections pursuant to section 4729.23 of the Revised Code.

(5) If applicable, a quality assurance review may be conducted by a quality assurance committee established in accordance with section 2305.24 of the Revised Code.

(D) When a pharmacy determines or has been notified that a dispensing error has occurred, a representative of the terminal distributor of dangerous drugs shall as soon as possible:

(1) Communicate to the patient or the patient's caregiver the fact that an error in dispensing has occurred, and the steps required to avoid harm or mitigate the error.

(2) Communicate to the prescriber the fact that an error in dispensing has occurred only if the error could result in potential or actual patient harm.

(3) The communication requirement of this paragraph shall only apply when a patient receives a drug that was the result of a dispensing error and the error poses harm to the patient. Harm includes impairment of the physical, emotional, or psychological function or structure of the body and/or pain resulting therefrom.

(4) The pharmacy shall maintain documentation that the communications requirements of this rule were completed. Such documentation shall be maintained for three years from the date of creation in a readily retrievable manner.

(E) If a pharmacy is notified of a dispensing error by the patient, the patient's caregiver, or a prescriber, a representative of the terminal distributor of dangerous drugs is not required to communicate with that individual as required in paragraph (D) of this rule.

(F) The terminal distributor of dangerous drugs shall inform pharmacy personnel of changes to pharmacy policy, procedure, systems, or processes made as a result of recommendations generated by the quality assurance program.

(G) Nothing in this rule shall be construed to prevent a pharmacy from contracting or otherwise arranging for the provision of personnel or other resources by a third party or administrative offices with such skill or expertise as the pharmacy believes to be necessary to satisfy the requirements of this rule.

(H) The pharmacy shall comply with the reporting requirements for dispensing errors pursuant to rule 4729:5-4-02 of the Administrative Code.

Last updated June 6, 2025 at 1:30 PM

History

Effective: June 6, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-23 Mobile clinics or medication units.

(A) The following may operate a mobile unit to dispense, personally furnish, or otherwise distribute or administer prescription medications and devices to individuals in this state without a fixed address or who would otherwise not have access to medication services:

(1) A nonprofit organization, corporation, or association as defined in the Ohio Revised Code; or

(2) A for-profit entity for the purpose of providing services to an individual needing treatment for a substance use disorder, a mental health condition, and any related medical issue.

(B) A mobile clinic or medication unit shall register for a no-cost, satellite license affiliated with an existing terminal distributor of dangerous drugs as specified by the board.

(1) Except as provided in paragraph (C)(2) of this rule, if distributing dangerous drugs that have already been dispensed or personally furnished in accordance with this division of the Administrative Code, the drugs must be in the full and actual charge of a licensed or registered health care professional authorized under Chapter 4715., 4723., 4729., 4730., 4731., or 4741. of the Revised Code.

(2) If transporting drugs for distribution and there is no healthcare professional present on the mobile unit, as described in paragraph (C)(1) of this rule, all dangerous drugs shall be secured using physical locks to prevent unauthorized access.

(3) If engaged in the following:

(a) Dispensing dangerous drugs: a licensed pharmacist shall be on the premises and the mobile unit shall be under the control and management of the pharmacist. All dispensing activities shall comply with the requirements of Chapter 4729:5-5 of the Administrative Code.

(b) Personally furnishing dangerous drugs: a licensed healthcare professional authorized to prescribe drugs shall be on the premises and the mobile unit shall be under the control and management of the licensed healthcare provider. All personally furnishing activities shall comply with the requirements of Chapter 4729:5-19 of the Administrative Code.

(4) Implement a record keeping system that will provide accountability for proper receipt, delivery, disposal, and return of all prescription medications in accordance with applicable record keeping provisions in division 4729:5 of the Administrative Code.

(5) Except for mobile units that are stored in a locked garage with access control, dangerous drugs shall not be left in the mobile unit during the hours that the mobile unit is not in operation. Without exception, a terminal distributor shall not maintain controlled substances in the mobile unit when the unit is not in use.

(6) All mobile units shall be dry, well lit, well ventilated, and maintained in a clean, sanitary, and orderly condition. Storage areas for dangerous drugs shall be maintained at temperatures and conditions which will ensure the integrity of the drugs as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(7) All mobile units shall be secured with suitable locks capable of preventing unauthorized access.

Last updated January 15, 2025 at 7:56 AM

History

Effective: January 15, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-24 Dispensing dangerous drugs to an alternate location.

(A) As used in this rule, "alternate location" means a location other than a patient or caregiver's address on file with the pharmacy that complies with the requirements set forth in this rule.

(B) This rule does not apply to a central fill pharmacy as defined in rules 4729:5-5-19 and 4729:5-9-02.13 of the Administrative Code.

(C) A pharmacy licensed as a terminal distributor of dangerous drugs may dispense dangerous drugs to an alternate location in accordance with this rule. An alternate location may include either:

(1) A pharmacy as defined in section 4729.01 of the Revised Code; or

(2) A location licensed as a terminal distributor of dangerous drugs or who is exempted from licensure in accordance with section 4729.541 of the Revised Code and all the following apply:

(a) The dispensing pharmacy maintains a record keeping system that provides accountability for the delivery, return, and, if returned, the disposal of all dangerous drugs dispensed in accordance with this division of the Administrative Code.

(b) There is clear and convincing evidence that delivery of a dangerous drug directly to the patient would result in:

(i) Danger or harm to public health or safety;

(ii) Danger or harm to the patient without increased involvement by a health care professional in the patient's drug therapy.

(c) The receipt, storage, control, and distribution of the dispensed dangerous drugs are in the full and actual charge of a health care professional licensed pursuant to Chapter 4715., 4723., 4729., 4730., 4731., or 4741. of the Revised Code and in accordance with the professional's scope of practice.

(d) There is a documented method in place to ensure compliance with rule 4729:5-5-09 of the Administrative Code.

(e) The dispensing complies with federal law, rules, and regulations.

(D) A terminal distributor of dangerous drugs that serves as an alternate location shall comply with the following:

(1) Maintain a record keeping system that will provide accountability for the receipt, disposal, and return of all dangerous drugs dispensed by the pharmacy in accordance with this division of the Administrative Code.

(2) Unless donated to a drug repository program pursuant to section 3715.87 of the Revised Code, a dangerous drug that is not distributed or administered to a patient shall either:

(a) Be returned to the dispensing pharmacy for disposal or, if applicable, returned to stock;

(b) Be disposed of in accordance the applicable rules set forth in this division of the Administrative Code.

(3) Except for terminal distributors of dangerous drugs who are pharmacies, only receive drugs from the dispensing pharmacy if there is clear and convincing evidence that the delivery of a dangerous drug directly to the patient would result in:

(a) Danger or harm to public health or safety; or

(b) Danger or harm to the patient without increased involvement by a health care professional in the patient's drug therapy.

(4) The location acknowledges that any patient specific dangerous drug dispensed by a pharmacy is the property of that patient, except that a dangerous drug that is not distributed or administered to that patient within six months of dispensation shall be deemed abandoned. A terminal distributor of dangerous drugs may do any of the following with an abandoned drug:

(a) Return the drug to the dispensing pharmacy for disposal or, if applicable, returned to stock;

(b) Be disposed of in accordance the applicable rules set forth in this division of the Administrative Code;

(c) Donate to a drug repository program in accordance with Chapter 4729:5-10 of the Administrative Code. For the purposes of meeting the requirements under division (H) of section 3715.873 of the Revised Code and rule 4729:5-10-06 of the Administrative Code, a terminal distributor of dangerous drugs that possesses an abandoned drug shall be deemed as the owner of the drug for the sole purpose of providing consent for the drug's donation to a drug repository program; or

(d) If dispensed by a pharmacy under common ownership and control as the receiving terminal distributor of dangerous drugs, the drug may be returned to stock in accordance with rule 4729:5-5-22 of the Administrative Code.

(5) Nothing shall authorize a terminal distributor of dangerous drugs to return to inventory or otherwise repurpose an abandoned drug for use on another patient, unless the terminal distributor:

(a) Operates a drug repository program in accordance with Chapter 4729:5-10 of the Administrative Code; or

(b) Returns the drug in accordance with paragraph (D)(4)(d) of this rule.

(E) The state board of pharmacy may restrict a site from acting as an alternate location if it has clear and convincing evidence that the activities of that location present the following:

(1) Danger or harm to public health or safety; or

(2) Danger or harm to the patient.

(F) No prescriber or pharmacy that provides a patient with a drug pursuant this rule shall charge any additional fees or require any additional monetary compensation for the dangerous drug.

(G) Paragraph (F) of this rule does not prohibit a prescriber or pharmacy from charging a patient for any of the following:

(1) The cost of an office visit or any expense related to the administration of a dangerous drug; or

(2) The cost of a dangerous drug dispensed by a pharmacy to a patient if paid for by the prescriber or pharmacy.

(H) Except as otherwise required by Ohio law, a patient or patient's caregiver shall have the exclusive right to determine if a pharmacy may sell or deliver dangerous drugs that have been dispensed by the pharmacy in the name of that patient to an alternate location.

Last updated August 19, 2026 at 9:41 AM

History

Effective: August 19, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-3-25 Electronic product verification.

(A) As used in this rule:

(1) "Electronic product verification" or "electronic verification" means the non-physical dispensation ("final check") of a drug or device by a pharmacist using an electronic verification system to verify the accuracy of the drug or device and affixed label prior to dispensing. Electronic final verification does not include the following:

(a) Operation of a remote dispensing pharmacy pursuant to Chapter 4729:5-18 of the Administrative Code;

(b) The practice of remote outpatient prescription processing pursuant to rule 4729:5-5-20 of the Administrative Code;

(d) The practice of personally furnishing by a prescriber pursuant to division 4729:5 of the Administrative Code; or

(e) The dispensation of a drug or device from an automated pharmacy system pursuant to rule 4729:5-3-17 of the Administrative Code.

(2) "Electronic verification system" means a system that complies with the requirements set forth in this rule.

(B) For a pharmacist to engage in electronic product verification, the pharmacist shall:

(1) Be licensed as a pharmacist in this state.

(2) Physically practice in a pharmacy licensed as a terminal distributor of dangerous drugs that is:

(a) Located in this state; and

(b) Under the same common ownership and control.

(3) Complete the required training and competency evaluations in paragraph (G) of this rule.

(4) Be a current or contracted employee of the pharmacy operating the electronic verification system.

(C) An electronic verification system shall allow the pharmacist to see exact, clear, and unobstructed visual images of the drug or device being dispensed and the label affixed to the container. The system shall, at a minimum, have high-definition image resolution with variable viewing options to accurately and safely dispense a drug or device and sufficient data retention capabilities to investigate any quality-related events.

(1) The system shall use barcoding technology to ensure the accuracy of drugs or devices dispensed in accordance with this rule. Barcodes shall be scanned, and not manually typed, into the system. The board may waive or modify the barcode technology requirements listed in this paragraph if the electronic verification system can provide an alternative method to ensure the accuracy of drugs or devices dispensed in accordance with this rule.

(2) The system shall produce images that are high definition with image resolution of at least 300 pixels per inch and in full color.

(3) If multiple units are being dispensed, the pharmacist must be able to see and verify an image or images of each unit and each individual affixed label.

(4) The images shall contain the following to ensure the pharmacist is able to appropriately verify the prescription prior to dispensing:

(a) A clear image of the prescription label affixed to the drug or device;

(b) The full quantity of the filled prescription;

(c) Except as provided in paragraph (C)(5) of this rule, the medication stock bottle or container and label of a drug that has been returned to stock in accordance with rule 4729:5-5-22 of the Administrative Code used to fill the prescription, if applicable;

(d) Clear markings present on the drug being dispensed (e.g., tablets, capsules, etc.), if applicable; and

(e) A clear image of the following, if not otherwise captured or maintained in the pharmacy system:

(i) The drug's national drug code, as defined in 21 CFR 207.33 (April 1, 2026), or global trade item number; and

(ii) The drug's serial number, lot number, and expiration date.

(5) The board may waive or modify the requirements listed in paragraph (C)(4)(c) of this rule if the electronic verification system can provide an alternative method that accurately captures information from the medication stock bottle and/or container and label of a drug that has been returned to stock in accordance with rule 4729:5-5-22 of the Administrative Code.

(6) The system shall use stock images of the correct drug, including markings if applicable.

(7) Images associated with the electronic product verification shall be retained in a secure, uniform, and electronic format and maintained for one year from the date of verification. Images associated with electronic product verification shall be made readily retrievable.

(8) Use of an electronic verification system shall be terminated if the system is not properly functioning. Prior to resuming the use of the system, the pharmacy shall identify the root cause or causes of the malfunction and shall validate that the system is properly functioning.

(9) The electronic verification system shall be capable of clearly communicating that the pharmacist has verified the drug or device prior to sale or distribution.

(10) Prior to dispensing, a pharmacist shall review and authorize overrides performed by a pharmacy technician or pharmacy intern of any technologically generated errors, warnings, alerts, or exceptions related to system functionality or verification/accuracy. Documentation of the pharmacist's review and authorization must be captured using electronic positive identification and maintained for three years from the date of review in a readily retrievable format.

(11) A pharmacist shall not be required to conduct electronic product verification if, in the pharmacist's professional judgement, the system, personnel, or processes employed by the pharmacy present a danger to the health and safety of patients.

(D) All electronic product verification shall be documented using an electronic form of positive identification in accordance with rule 4729:5-5-04 or rule 4729:5-9-02.3 of the Administrative Code.

(E) No further manipulation of a drug or device shall occur after the pharmacist's electronic verification is complete other than applying the required container lid or seal. Manipulation does not include preparing a finished prescription/medication order for mailing, sale, delivery, or storage.

(F) Except as provided for in this paragraph, a pharmacist shall not conduct electronic product verification of compounded drug preparations. A pharmacist may utilize electronic product verification as part of the compounding process as follows:

(1) The pharmacist complies with all applicable requirements of this rule.

(2) Only components used for compounded drug preparations may be verified by a pharmacist using an electronic verification system.

(3) Reconstituted drug products (ex. stock solutions) may be used or manipulated for compounding after the pharmacist's electronic verification is complete.

(4) At the completion of the compounding process and prior to release or dispensation, sale, or distribution, the compounded drug preparation shall be visually inspected by a pharmacist in person to determine whether the physical appearance of the drug is as expected (e.g., free of inappropriate visible particulates or other foreign matter, discoloration, or other defects) and that the container closure integrity is in compliance with all applicable United States Pharmacopeia chapters referenced in rule 4729:7-1-01 of the Administrative Code. A pharmacist shall document this verification using positive identification.

(G) All pharmacy personnel utilizing an electronic final verification system must be trained and competent to perform the duties assigned and have a documented initial assessment of competency using the pharmacy's electronic verification system. Additional documented assessments shall be required in the event of a substantive change to the system's functionality or in the event of a major system update.

(H) An electronic verification system shall be implemented and validated by the vendor or manufacturer with oversight by an Ohio-licensed pharmacist prior to initial use to ensure proper functioning. The system shall be validated in accordance with the pharmacy's policies and procedures at least annually and upon the addition of new processes or material system changes.

(1) Validation is a documented process established by the terminal distributor of dangerous drugs that proves the electronic verification system consistently operates according to its intended use, specifications, and requirements of this rule.

(2) Proof of compliance with validation requirements shall be documented by the vendor or manufacturer and maintained in a readily retrievable format for three years from the date of validation or revalidation.

(3) The records shall document the positive identification of the pharmacist responsible for overseeing the required validation, date(s) performed, and the results of the validation.

(I) Pharmacies using an electronic verification system as authorized by this rule shall maintain an ongoing and documented quality assurance system that monitors the performance of the electronic verification system to ensure proper and accurate functioning in accordance with rule 4729:5-3-22 of the Administrative Code. The quality assurance system shall also include procedures for reporting system malfunctions.

(J) Pharmacies utilizing an electronic verification system pursuant to this rule shall maintain and implement written policies and procedures governing all aspects of electronic verification activities. Such policies and procedures shall be maintained in a readily retrievable format and shall include, but are not limited to, the following:

(1) Staff training and competency assessments;

(2) Operation of the quality assurance system, including reporting, investigating and addressing errors, system malfunctions, and other quality assurance issues;

(3) Validation and revalidation of electronic verification technology to ensure proper functioning; and

(4) System maintenance, including any routine or preventive maintenance.

(K) Pharmacies using an electronic verification system shall comply with all applicable record keeping requirements pursuant to rule 4729:5-5-04 or rule 4729:5-9-02.3 of the Administrative Code.

(L) A pharmacy licensed as a terminal distributor of dangerous drugs that is engaged in electronic product verification shall comply with all minimum standards for the operation of a pharmacy, including rule 4729:5-5-02 of the Administrative Code and all supplemental rules adopted thereunder.

Last updated August 19, 2026 at 9:40 AM

History

Effective: August 19, 2026
Promulgated Under: 119.03

Chapter 4729:5-4 Discipline

Ohio Adm.Code 4729:5-4-01 Disciplinary actions.

(A) The state board of pharmacy, in accordance with Chapter 119. of the Revised Code, may impose any one or more of the following sanctions on a person licensed as a terminal distributor of dangerous drugs for any of the causes set forth in paragraph (B) of this rule:

(1) Suspend, revoke, restrict, limit, or refuse to grant or renew a license;

(2) Reprimand or place the license holder on probation;

(3) Impose a monetary penalty or forfeiture as set forth in section 4729.57 of the Revised Code.

(B) The board may impose the sanctions set forth in paragraph (A) of this rule for any of the following:

(1) Making any false material statements in an application for a license or renewal of a license as a terminal distributor of dangerous drugs.

(2) Violating any rule of the board.

(3) Violating any provision of Chapter 4729. of the Revised Code.

(4) Except as provided in section 4729.89 of the Revised Code, violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, or Chapter 3715. of the Revised Code.

(5) Violating any provision of the federal drug abuse control laws or Chapter 2925. or 3719. of the Revised Code.

(6) Falsely or fraudulently promoting to the public a dangerous drug, except that nothing in this rule prohibits a terminal distributor of dangerous drugs from furnishing information concerning a dangerous drug to a health care provider or another licensed terminal distributor.

(7) Ceasing to satisfy the qualifications of a terminal distributor of dangerous drugs set forth in section 4729.55 of the Revised Code.

(8) Except as provided in division (C) of section 4729.57 of the Revised Code:

(a) Waiving the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the services provided by a terminal distributor of dangerous drugs, would otherwise be required to pay for the services if the waiver is used as an enticement to a patient or group of patients to receive pharmacy services from that terminal distributor;

(b) Advertising that the terminal distributor will waive the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the pharmaceutical services, would otherwise be required to pay for the services.

(9) Conviction of a felony.

(10) Violation of any restrictions placed by the state board of pharmacy on a license or violating any terms of a board order issued against the licensee.

(11) Exclusion from participation in medicare or a state health care program.

(12) Being denied a license or registration by the drug enforcement administration or appropriate issuing body of any state or jurisdiction.

(13) Being the subject of any of the following by the drug enforcement administration or licensing agency of any state or jurisdiction:

(a) A disciplinary action that resulted in the suspension or revocation of the person's license or registration; or

(b) A disciplinary action that was based, in whole or in part, on the person's inappropriate prescribing, dispensing, diverting, administering, storing, personally furnishing, compounding, supplying or selling a controlled substance or other dangerous drug.

(14) Commission of an act that constitutes a disqualifying offense, regardless of the jurisdiction in which the act was committed.

(15) Has been subject to any of the following:

(a) A finding by a court of the person's eligibility for intervention in lieu of conviction; or

(b) A finding by a court of the person's eligibility for treatment or intervention in lieu of conviction in another jurisdiction.

(16) Has been granted entry into a diversion program, deferred prosecution program, or the equivalent thereof.

(17) Is addicted to or abusing alcohol or drugs.

(18) Commission of an act that constitutes a misdemeanor that is related to, or committed in, the person's professional practice.

(19) Employs a responsible person that does not meet the requirements set forth in rule 4729:5-2-01 of the Administrative Code.

(20) The ownership of such entity has been transferred from a person whose license issued in accordance with Chapter 4729. of the Revised Code has been revoked or disciplined by the state board of pharmacy or any other professional licensing agency to a spouse or other family member.

(21) The ownership of such facility has been transferred from a licensee whose license has been revoked or disciplined by the state board of pharmacy or any other professional licensing agency to another who employs the former owner or who allows the former owner to be present within the physical confines of the location to be licensed.

(22) Except as provided in Chapter 3719. of the Revised Code, dispensing a sample drug as defined in rule 4729:6-3-08 of the Administrative Code.

(23) The method used by the terminal distributor to store, possess or distribute dangerous drugs poses serious harm to others.

(24) The furnishing of false or fraudulent information or omitting information on due diligence questionnaires and/or attestation documents regarding the purchase or receipt of dangerous drugs from manufacturers, repackagers, third-party logistics providers, outsourcing facilities, wholesale distributors or other terminal distributors.

(25) Retaliating against or disciplining an employee for filing a complaint with a board of pharmacy or other licensing body or reporting a violation of state or federal statute or any ordinance or regulation of a political subdivision that the employee's employer has authority to correct. As used in this rule, retaliation or discipline of an employee includes, but is not limited to, the following:

(a) Removing or suspending the employee from employment;

(b) Withholding from the employee salary increases or employee benefits to which the employee is otherwise entitled;

(d) Denying the employee a promotion that otherwise would have been received;

(e) Reducing the employee in pay or position.

(26) Unless otherwise approved by the board, a terminal distributor knowingly employs a person with access to drug stock who:

(a) Has been denied the right to work in any facility by the state board of pharmacy as part of an official order of the board.

(b) Has been denied the right to work in such a facility by another professional licensing agency as part of an official order of that agency.

(c) Has committed an act that constitutes a disqualifying offense, regardless of the jurisdiction in which the act was committed.

(d) Has committed an act that constitutes a misdemeanor or felony drug offense, except for a minor misdemeanor drug offense, regardless of the jurisdiction in which the act was committed.

(e) Has been subject to any of the following:

(i) A finding by a court of the person's eligibility for intervention in lieu of conviction; or

(ii) A finding by a court of the person's eligibility for treatment or intervention in lieu of conviction in another jurisdiction.

(f) Has been granted entry into a diversion program, deferred prosecution program, or the equivalent thereof.

(g) Is addicted to or abusing alcohol or drugs.

(h) Has been excluded from participation in medicare or a state health care program.

(i) Has been denied a license or registration by the drug enforcement administration or appropriate issuing body of any state or jurisdiction.

(j) Has been the subject of any of the following by the drug enforcement administration or licensing agency of any state or jurisdiction:

(i) A disciplinary action that resulted in the suspension, probation, surrender or revocation of the person's license or registration; or

(ii) A disciplinary action that was based, in whole or in part, on the person's inappropriate prescribing, dispensing, diverting, administering, storing, securing, personally furnishing, compounding, supplying or selling a controlled substance or other dangerous drug.

(k) Has committed an act that constitutes a misdemeanor that is related to, or committed in, the employee's professional practice.

Last updated July 1, 2026 at 12:19 PM

History

Effective: April 25, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-4-02 Duty to Report.

(A) As used in this rule:

(1) "Dishonesty" means any action by a licensee, registrant or applicant to include, but is not limited to, making any statement that deceives, misrepresents or misleads, or be a party to or an accessory to any fraudulent or deceitful practice or transaction in the practice of pharmacy or in the operation or conduct of a pharmacy.

(2) "Dispensing error" or "error in dispensing" has the same meaning as rule 4729:5-3-22 of the Administrative Code.

(3) "Reckless behavior" means a person who acts recklessly or who is reckless. A person acts recklessly when, with heedless indifference to the consequences, the person disregards a substantial and unjustifiable risk that the person's conduct is likely to cause a certain result or is likely to be of a certain nature. A person is reckless with respect to circumstances when, with heedless indifference to the consequences, the person disregards a substantial and unjustifiable risk that such circumstances are likely to exist.

(4) "Unprofessional conduct" means conduct that is detrimental to the best interests of the public, including conduct that endangers the health, safety or welfare of a patient or client. Such conduct shall include, but not be limited to, the following acts: coercion, intimidation, harassment, sexual harassment, improper use of private health information, threats, degradation of character, indecent or obscene conduct, and theft.

(B) A pharmacy licensed as a terminal distributor of dangerous drugs shall be required to report, from direct observation or objective evidence, the following to the board in accordance with paragraph (C) of this rule:

(1) Any error in dispensing when the error is the result of reckless behavior.

(2) Any error in dispensing where the error results in any of the following per the "National Coordinating Council for Medication Error Reporting and Prevention Medication Error Index (Revised 2/20/2001)":

(a) Category G: an error occurred that resulted in permanent patient harm.

(b) Category H: an error occurred that resulted in a near-death event (e.g., anaphylaxis, cardiac arrest).

(3) The termination or resignation of employment of any individual licensed or registered by the board that was based, in whole or in part, on an error or errors in dispensing.

(4) The termination or resignation of employment of any individual licensed or registered by the board that was based, in whole or in part, on engaging in unprofessional conduct, dishonesty, or reckless behavior.

(5) The termination or resignation of employment of any individual licensed or registered by the board that was based, in whole or in part, on conduct indicating an individual licensed or registered by the board is practicing pharmacy while physically or mentally impaired by alcohol, drugs or other chemical substances or impaired physically or mentally to such a degree as to render the individual unfit to carry out their professional duties.

(C) Reporting required in accordance with this rule shall be made by mail, using the board's online complaint form (available on the board's website: www.pharmacy.ohio.gov), or telephone and shall include the following information:

(1) The name of the employer and the employer's terminal distributor license number;

(2) The full name and license or registration number of the licensee or registrant for which a report is being made;

(3) If applicable, an explanation of the error in dispensing that occurred, including details regarding any patient harm;

(4) If applicable, an explanation of the circumstances that resulted in the individual's termination or resignation from employment; and

(5) The date(s) of and place(s) of occurrence(s), if known.

(D) All reports submitted in accordance with this rule shall protect the confidentiality of patients. The Board may request additional information, including patient information, as part of an investigation conducted in accordance with Chapter 4729. of the Revised Code.

(E) All required reporting shall be submitted to the board no later than:

(1) For an error in dispensing pursuant to paragraphs (B)(1) to (B)(3) of this rule, ten days from the date the quality assurance program review in accordance with rule 4729:5-3-22 of the Administrative Code was completed; and

(2) For the termination or resignation of an employee pursuant to paragraphs (B)(4) and (B)(5) of this rule, ten days from the date the individual is terminated or resigns from employment.

(F) Notwithstanding any provision of agency 4729 of the Administrative Code, a pharmacist, pharmacy intern, certified pharmacy technician, registered pharmacy technician, or pharmacy technician trainee shall not be required to make a report to the board pursuant to the applicable duty to report rules in divisions 4729:1, 4729:2, and 4729:3 of the Administrative Code if the licensee or registrant is employed by or under contract with a pharmacy licensed as a terminal distributor of dangerous drugs and the terminal distributor submits a report in accordance with this rule.

(G) In accordance with section 4729.23 of the Revised Code, information submitted to the board in accordance with this rule shall be deemed confidential, is not a public record, and is not subject to discovery in any civil action.

Last updated May 19, 2026 at 4:58 PM

History

Effective: March 1, 2025
Promulgated Under: 119.03

Chapter 4729:5-5 Outpatient Pharmacies

Ohio Adm.Code 4729:5-5-01 Definitions - outpatient pharmacies.

As used in Chapter 4729:5-5 of the Administrative Code:

(A) "Audit trail" means all materials and documents required for the entire processing of a prescription, which shall be sufficient to document or reconstruct the origin of the prescription and authorization of subsequent modifications of that prescription.

(B) "Dispense" means the final association of a drug with a particular patient pursuant to a prescription, drug order, or other lawful order of a prescriber and the professional judgment of and the responsibility for interpreting, preparing, compounding, labeling, and packaging a specific drug.

(C) "OARRS report" means a report of information related to a specific person generated by the drug database established and maintained pursuant to section 4729.75 of the Revised Code.

(D) "Original prescription" means any of the following issued in accordance with division 4729:5 of the Administrative Code:

(1) A prescription issued by a prescriber in writing;

(2) An oral prescription transcribed by a pharmacist, pharmacy intern, or certified pharmacy technician;

(3) An electronically transmitted prescription; or

(4) A prescription transmitted by use of a facsimile machine.

(E) "Personal supervision" or "direct supervision" means a pharmacist shall be physically present in the pharmacy, or in the area where the practice of pharmacy is occurring, to provide personal review and approval of all professional activities.

(F) "Pharmacy," except when used in a context that refers to the practice of pharmacy, means any area, room, rooms, place of business, department, or portion of any of the foregoing where the practice of pharmacy is conducted.

(G) "Pharmacist" means an individual who holds a current pharmacist license pursuant to Chapter 4729. of the Revised Code.

(H) "Outpatient pharmacy" means any pharmacy, including a clinic pharmacy, where drugs are dispensed for outpatient use. It does not include institutional pharmacies or institutional facilities, as defined in agency 4729 of the Administrative Code, where drugs are dispensed for use by inpatients. An outpatient pharmacy shall comply with all requirements set forth in this chapter.

(I)

(1) "Positive identification" means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following, as authorized under this chapter of the Administrative Code:

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(g) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who performed the action requiring positive identification. The printout must be maintained for three years and made readily retrievable; or

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier.

(J) "Practice of pharmacy" has the same meaning as in division (B) of section 4729.01 of the Revised Code.

(K) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(L) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

Last updated July 7, 2025 at 7:21 PM

History

Effective: July 7, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-02 Minimum standards for the operation of an outpatient pharmacy.

(A) As used in this rule, "pharmacy personnel" means any of the following licensed or registered in accordance with Chapter 4729. of the Revised Code:

(1) Pharmacist;

(2) Pharmacy intern;

(3) Certified pharmacy technician;

(4) Registered pharmacy technician;

(5) Pharmacy technician trainee.

(B) In accordance with division (D) of section 4729.55 of the Revised Code, an outpatient pharmacy licensed as a terminal distributor of dangerous drugs shall:

(1) Ensure sufficient personnel are scheduled to work at all times in order to minimize fatigue, distraction, or other conditions which interfere with a pharmacist's ability to practice with reasonable competence and safety. Staffing levels shall not be solely based on prescription volume but shall consider any other requirements of the practice of pharmacy by pharmacy personnel during working hours.

(2) Provide sufficient tools and equipment in updated and good repair. All tools and equipment shall be housed in a suitable, well-lit, and well-ventilated room or department and maintained in a clean, sanitary, and orderly condition.

(3) Provide pharmacy personnel with access to the following:

(a) All current federal and state laws, regulations, and rules governing the practice of pharmacy and legal distribution of drugs in Ohio, including internet access to:

(i) The board's website (www.pharmacy.ohio.gov);

(ii) Ohio laws and administrative rules (https://codes.ohio.gov)

(iii) The code of laws of the United States of America (variously abbreviated to Code of Laws of the United States, United States Code, U.S. Code, U.S.C., or USC); and

(iv) The code of federal regulations.

(b) References necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and to comply with all state and federal laws, this shall include hard copy or internet access to appropriate pharmacy reference materials.

(4) Ensure pharmacy personnel are sufficiently trained to safely and adequately perform their assigned duties.

(5) Maintain a stock of drugs sufficient to compound and prepare the types of prescriptions offered by the pharmacy.

(6) Maintain a stock of prescription containers necessary to dispense drugs in accordance with federal and state laws, including the provisions of the federal Poison Prevention Act of 1970 and compendial standards, or as recommended by the manufacturer or distributor for non-compendial drug products.

(7) Ensure all areas where drugs and devices are stored and prepared are dry, well-lit, well-ventilated, and maintained in a clean, sanitary, and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the drugs prior to their dispensing or administering as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(8) For outpatient pharmacies open to the public, publicly post the operating hours of the pharmacy department.

(9) Ensure all employees of the pharmacy are identified by a name tag that includes the employee's job title and, if a pharmacy technician, the technician's registration type pursuant to Chapter 4729:3-3 of the Administrative Code.

(10) Provide adequate security for all dangerous drugs in accordance with the requirements of agency 4729 of the Administrative Code. A pharmacy shall maintain the current contact information for the pharmacy's security system vendor and shall immediately provide this information upon the request of an agent, inspector, or employee of the board.

(11) Provide sufficient time for pharmacists to complete professional duties and responsibilities, including:

(a) Drug utilization review;

(b) Immunization;

(d) Dispensing of prescriptions;

(e) Patient testing; and

(f) All other duties of a pharmacist as authorized by Chapter 4729. of the Revised Code.

Last updated October 7, 2025 at 3:56 PM

History

Effective: May 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-02.1 Provision of Ancillary Services in an Outpatient Pharmacy.

(A) As used in this rule, "ancillary services" are services performed by pharmacy personnel that are performed in addition to, or outside of, the dispensation of dangerous drugs.

(1) Ancillary services include, but are not limited to, immunizations, drug administration, medication therapy management, disease state management, and refill reminders.

(2) Ancillary services do not include services provided by an outpatient pharmacy to patients upon discharge from an institutional facility as defined in Chapter 4729:5-9 of the Administrative Code.

(B) In accordance with division (D) of section 4729.55 of the Revised Code, an outpatient pharmacy licensed as a terminal distributor of dangerous drugs shall not establish any quotas relating to the provision of ancillary services.

(1) For purposes of this rule, "quota" means a fixed number or formula related to the duties of pharmacy personnel, against which the pharmacy or its agent measures or evaluates the number of times either an individual performs tasks or provides services while on duty.

(2) For purposes of this rule, "quota" does not mean any of the following:

(a) A measurement of the revenue earned by a pharmacy not calculated in relation to, or measured by, the tasks performed, or services provided by pharmacy personnel.

(b) Any evaluation or measurement of the competence, performance, or quality of care provided to patients of pharmacy personnel if the evaluation does not use quotas.

Last updated May 1, 2024 at 8:40 AM

History

Effective: May 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-02.2 Mandatory Rest Breaks for Pharmacy Personnel.

(A) An outpatient pharmacy licensed as a terminal distributor of dangerous drugs shall not require pharmacy personnel to work longer than thirteen hours in any workday and shall allow at least eight hours of off time between consecutive shifts.

(1) A pharmacist may volunteer to work longer than thirteen continuous hours.

(2) The pharmacy must document and date the amount of time worked beyond the thirteen hour limit along with the reason and make it available in the pharmacy for immediate inspection for at least three years from the date it was created.

(B) Pharmacy personnel working longer than six continuous hours per workday shall be allowed during that time to take a thirty-minute, uninterrupted rest break.

(1) Unless as provided in paragraph (B)(2) of this rule, a pharmacist that takes a break in accordance with this rule shall remain on the premises of the pharmacy during the meal/rest break and shall be available for emergencies.

(2) The requirement in paragraph (B)(1) of this rule does not apply in either case:

(a) There are two or more pharmacists working in the pharmacy and the pharmacists stagger their rest breaks so that the pharmacy is not left without a pharmacist on duty.

(b) The pharmacy closes for the required rest break. If a pharmacy closes for a required rest break, the pharmacy shall implement a regular break schedule and communicate the break schedule to customers wherever pharmacy hours are publicly posted or communicated.

(C) The requirements of paragraph (B) of this rule do not apply to outpatient pharmacies that are not open to the public (e.g., closed door pharmacies). An outpatient pharmacy that is not open to the public shall still be required to allow all pharmacy personnel working longer than six continuous hours to take a thirty-minute, uninterrupted rest period and meal break.

(D) Only prescriptions dispensed by a pharmacist pursuant to this chapter of the Administrative Code may be sold when the pharmacist is on break. An offer to counsel any person filling a prescription shall be offered pursuant rule 4729:5-5-09 of the Administrative Code. Persons who request to speak to the pharmacist shall be told that the pharmacist is on break and that they may wait to speak with the pharmacist or provide a telephone number for the pharmacist to contact them upon return from break. Pharmacists returning from break shall immediately attempt to contact persons who requested counseling.

(E) An outpatient pharmacy shall not retaliate or discipline a pharmacist for refusing to work longer than thirteen hours or pharmacy personnel that opt to take breaks in accordance with this rule. As used in this rule, retaliation or discipline of an employee includes, but is not limited to, the following:

(1) Removing or suspending the employee from employment;

(2) Withholding from the employee salary increases or employee benefits to which the employee is otherwise entitled;

(3) Transferring or reassigning the employee;

(4) Denying the employee a promotion that otherwise would have been received;

(5) Reducing the employee in pay or position.

Last updated May 1, 2024 at 8:40 AM

History

Effective: May 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-02.3 Requests for additional staff and reports of staffing concerns in an outpatient pharmacy.

(A) An outpatient pharmacy shall develop a process for pharmacy staff to communicate requests for additional staff or reports of staffing concerns. Requests for additional staff or reports of staffing concerns shall be communicated and documented by the responsible person or pharmacist on duty to the terminal distributor.

(B) Executed requests for additional staffing or reports of staffing concerns shall be provided to the immediate supervisor of the responsible person or pharmacist on duty, with one copy maintained in the pharmacy for three years for immediate inspection by an agent, inspector, or employee of the board.

(C) Outpatient pharmacies licensed as terminal distributors of dangerous drugs shall review all requests and reports of concern submitted in accordance with this rule and shall resolve any issues listed in a timely manner to ensure a safe working environment for pharmacy staff as required by section 4729.55 of the Revised Code. A written response to the request or report of concern shall occur within fourteen business days of submission and be communicated to the responsible person or pharmacy staff who submitted the request for additional staffing or report of concern. A copy of this response shall be maintained in the pharmacy for three years for immediate inspection by an agent, inspector, or employee of the board.

(D) An outpatient pharmacy shall not retaliate or discipline pharmacy personnel who, in good faith, make a request for additional staff or report staffing concerns in accordance with this rule. As used in this rule, retaliation or discipline of an employee includes, but is not limited to, the following:

(1) Removing or suspending the employee from employment;

(2) Withholding from the employee salary increases or employee benefits to which the employee is otherwise entitled;

(3) Transferring or reassigning the employee;

(4) Denying the employee a promotion that otherwise would have been received;

(5) Reducing the employee in pay or position.

Last updated July 25, 2024 at 8:25 AM

History

Effective: July 25, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-02.4 Significant Delays in the Provision of Pharmacy Services.

(A) An outpatient pharmacy has a duty to properly dispense lawful prescriptions for dangerous drugs or devices without significant delay.

(1) For purposes of this rule, "significant delay" means a prescription that was submitted to the pharmacy for processing by a prescriber, patient, or caregiver and has yet to be dispensed (e.g., final verification) by a pharmacist as follows:

(a) For new prescriptions: within three business days of receiving the prescription.

(b) For refill prescriptions not generated by a pharmacy auto-refill program: within three business days of receiving the prescription.

(c) For refill prescriptions generated by a pharmacy auto-refill program: within five business days of receiving the prescription.

(2) Receipt of the prescription as described in paragraph (A)(1) of this rule is said to occur:

(a) For new prescriptions: receipt occurs on the day when the prescription is transmitted or submitted to the pharmacy.

(b) For refills on existing prescriptions: receipt occurs on the day when a refill request is submitted to the pharmacy by a patient, caregiver, or prescriber or when a refill request is generated as part of a pharmacy's auto-refill program.

(3) For purposes of this rule, "significant delay" does not mean any of the following:

(a) A prescription that has been submitted to the pharmacy but where there is a documented drug shortage, or the pharmacy documents the drug is not available from the pharmacy's drug distributor.

(b) A prescription that has been submitted to the pharmacy that requires clarification or consultation by the issuing prescriber.

(c) A prescription that has been submitted to the pharmacy that requires prior authorization or is otherwise delayed because of the patient's prescription insurance coverage.

(d) A prescription that is for a compounded drug product.

(e) A prescription that the pharmacist, using their professional judgement, determines is of questionable, doubtful, or suspicious origin.

(f) A prescription that, in the pharmacist's professional judgment, if dispensed, cannot be safely provided or may negatively impact patient care.

(g) A prescription where the prescriber indicates a "do not fill until" date or similar designation.

(h) A prescription where the patient, caregiver, or issuing prescriber has communicated to the pharmacy that dispensing may occur beyond the period described in paragraph (A)(1) of this rule.

(i) A prescription where the patient, caregiver, or issuing prescriber has requested a transfer to another pharmacy.

(j) A prescription where the pharmacy has experienced any of the following:

(i) A natural disaster (fire, flood, etc.), civil unrest, or human made disaster;

(ii) An outbreak of a pandemic illness or the declaration of a state or federal public health emergency;

(iii) A loss of power; or

(iv) An unplanned information technology system outage.

(k) Any other circumstance as determined by the board.

(B) Each prescription that experiences a significant delay, as defined in paragraph (A) of this rule, shall be considered a violation of this rule and shall subject the outpatient pharmacy to disciplinary action in accordance with rule 4729:5-4-01 of the Administrative Code.

(C) Immediately upon discovery or at the request of an agent, inspector, or employee of the board, a pharmacy experiencing a significant delay shall implement one or more of the following remediation measures to dispense all prescriptions that are experiencing a significant delay:

(1) Limiting pharmacy hours (e.g., dark hours);

(2) Transferring prescriptions to another pharmacy, upon patient consent;

(3) Increasing pharmacy staff; or

(4) Any other strategy that is mutually agreed upon by the outpatient pharmacy and the agent, inspector, or employee of the board.

(D) As part of the remediation process required in paragraph (C) of this rule, the outpatient pharmacy shall implement a process that triages lifesaving and life-sustaining medications that are experiencing a significant delay.

(E) As used in this rule, "business day" means any day, excluding holidays, where the pharmacy is open for business.

(F) An outpatient pharmacy shall only provide auto-refills of a prescription upon the authorization of the patient or the patient's caregiver.

(1) The pharmacy shall maintain documentation indicating the patient or the patient's caregiver has enrolled in the pharmacy's auto-refill program.

(2) Consent for enrollment in the pharmacy's auto-refill program may be captured electronically, verbally by pharmacy staff, or in writing.

(3) The pharmacy shall maintain a record of consent in the patient's profile, or another system maintained by the pharmacy, in a readily retrievable manner. As part of this record, the pharmacy shall document the date the patient or caregiver consented to enrollment in the pharmacy's auto-refill program.

(4) The pharmacy shall discontinue enrollment in an auto-refill program upon the request of the patient or the patient's caregiver.

Last updated May 1, 2024 at 8:41 AM

History

Effective: May 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-02.5 Outpatient Pharmacy Access Points.

(A) As used in this rule, "ancillary services" are those services performed by pharmacy personnel that are not directly involved in the dispensation of dangerous drugs. Examples of such services include, but are not limited to, immunizations, drug administration, medication therapy management, disease state management, and refill reminders.

(B) Except as provided for in paragraph (C) of this rule, a pharmacy shall develop and implement an effective organizational policy that permits a pharmacist to do all the following:

(1) Limit the provision of ancillary services if, in the pharmacist's professional judgment, the provision of such services cannot be safely provided or may negatively impact patient access to medications. The pharmacy's policy shall include an offer by pharmacy staff to make an appointment for a patient or refer a patient to another location offering immunizations and other ancillary services.

(2) Limit pharmacy access points, if, in the pharmacist's professional judgment, limiting such access points will minimize fatigue, distraction, or other conditions which interfere with a pharmacist's ability to practice with reasonable safety and competence.

(C) In the absence of an organizational policy described in paragraph (B) of this rule, an outpatient pharmacy shall not override the control of the pharmacist on duty as follows:

(1) A pharmacist's decision not to administer or supervise immunizations or provide other ancillary services if, in the pharmacist's professional judgment, the provision of such services cannot be provided safely or may negatively impact patient access to medications. The pharmacy staff shall offer to make an appointment for the patient or may refer the patient to another location offering immunizations and other ancillary services.

(2) A pharmacist's decision to limit pharmacy access points if, in the pharmacist's professional judgment, limiting such access points will minimize fatigue, distraction, or other conditions which interfere with a pharmacist's ability to practice with reasonable safety and competence. Such limitations shall not interfere with a patient's ability to drop off or receive dispensed prescriptions during the pharmacy's posted hours of operation.

(D) Organizational policies developed in accordance with paragraph (A) of this rule shall be maintained in the pharmacy for immediate inspection by an agent, inspector, or employee of the board.

(E) This rule does not apply to outpatient pharmacies that are not open to the public (e.g., closed door pharmacies).

(F) An outpatient pharmacy shall not retaliate or discipline a pharmacist who, in good faith, acts in accordance with this rule. As used in this rule, retaliation or discipline of an employee includes, but is not limited to, the following:

(1) Removing or suspending the employee from employment;

(2) Withholding from the employee salary increases or employee benefits to which the employee is otherwise entitled;

(3) Transferring or reassigning the employee;

(4) Denying the employee a promotion that otherwise would have been received;

(5) Reducing the employee in pay or position.

Last updated May 1, 2024 at 8:41 AM

History

Effective: May 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-03 Filing and storage of prescriptions.

All original outpatient prescriptions shall be filed in the following manner:

(A) Prescriptions for schedule II controlled substances shall be maintained in a separate prescription file for schedule II prescriptions.

(B) Prescriptions for schedule III, IV, and V controlled substances shall be maintained in a separate prescription file for schedule III, IV, and V prescriptions.

(C) Prescriptions for non-controlled substances shall be maintained in a separate prescription file for non-controlled prescriptions.

(D) Prescriptions containing multiple drug orders shall be filed in the most restrictive file.

(E) All non-controlled hard copy prescriptions, including facsimiles, maintained pursuant to this rule may be electronically maintained, provided that the system creates and maintains electronic records in accordance with the following:

(1) All hard copy prescriptions for non-controlled dangerous drugs may be electronically filed and then destroyed after one hundred and eighty days from the date of creation or receipt. Disposal of the hard copy shall use a secure method of destruction to ensure privacy and confidentiality of the contents.

(2) All hard copy prescriptions electronically filed in accordance with this rule shall be scanned front and back in full color (i.e. retains color information and/or color graphics in the document) via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user. Prior to scanning, the written or faxed prescription shall be clearly notated to indicate it has been received by the pharmacy in a manner that does not destroy any of the original information contained on the prescription but prevents the unauthorized duplication of the prescription.

(3) A record or image once created shall be unalterable but may be annotated as necessary so long as the original record or image is still available for review and the individual that made the annotation is noted.

(4) The electronic form shows the exact and legible image of the original hard copy prescription.

(5) All hard copy prescriptions filed electronically in accordance with this rule shall be deemed the original prescription.

(F) All electronically transmitted prescriptions, including faxed prescriptions received in an electronic format, shall be electronically stored and maintained in accordance with this rule.

(G) All electronic systems used to maintain prescription images or data shall:

(1) Contain security features to prevent unauthorized access to the records; and

(2) Contain daily back-up functionality to protect against loss of records.

(H) All prescription records stored in accordance with this rule shall be uniformly maintained for a period of three years.

(I) An outpatient pharmacy shall ensure that original prescriptions are properly filed in compliance with this rule and rule 4729:5-5-13 of the Administrative Code.

Last updated July 10, 2026 at 11:18 AM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-04 Record keeping.

(A) There shall be positive identification of the licensed or registered individuals responsible for performing the following activities authorized under Chapter 4729. of the Revised Code and agency 4729 of the Administrative Code:

(1) Prescription information entered into the record keeping system. This provision shall take effect one-year from the effective date of this rule.

(2) Verification by the pharmacist of the prescription information entered into the record keeping system.

(3) Prospective drug utilization review, which shall be captured as a standalone action or as part of either:

(a) The pharmacist verification of prescription information in paragraph (A)(2) of this rule; or

(b) The dispensing process in paragraph (A)(4) of this rule.

(4) Dispensing.

(5) Compounding.

(6) Administering immunizations pursuant to section 4729.41 of the Revised Code.

(7) Administering injectable drugs pursuant to section 4729.45 of the Revised Code.

(8) Prescription information transcribed from an order received by telephone, facsimile, or recording device.

(9) Any changes or annotations made to a prescription.

(B) All records maintained in accordance with this rule shall be uniformly maintained for a period of three years.

(C) Record keeping systems shall provide immediate retrieval via digital display and hard copy printout or other mutually agreeable transfer medium of information for all prescriptions dispensed within the previous twelve months and shall provide, in a manner that is readily retrievable, information on all prescriptions dispensed beyond the previous twelve months but within the previous three years. This information shall include, at a minimum, the following data:

(1) The original prescription number;

(2) Date of issuance of the original prescription order by the prescriber;

(3) Full name of the patient for whom the drug is intended; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals;

(4) Residential address, including the physical street address and telephone number of the patient or owner;

(5) Full name and address of the prescriber, including the physical address of the prescriber's practice location;

(6) The prescriber's credential (MD, DDS, DVM, etc.), if indicated on the prescription;

(7) Directions for use;

(8) The brand name, if any, or the generic name and the name of the manufacturer or distributor or national drug code of the drug or device dispensed;

(9) The strength, dosage form, and quantity of the drug or device dispensed;

(10) The prescriber's federal drug enforcement administration number, if applicable;

(11) The positive identification of the persons performing specific actions pursuant to paragraph (A) of this rule;

(12) The total number of refills authorized by the prescriber;

(13) The date of dispensing;

(14) The refill history of the prescription, including all of the following:

(a) The prescription number;

(b) The brand name, if any, or the generic name and the name of the manufacturer or distributor or national drug code of the drug or device dispensed;

(d) The quantity dispensed.

(D) A pharmacy that utilizes a computerized system to dispense dangerous drugs that is unable to electronically document positive identification in accordance with paragraph (A) of this rule shall be required to maintain hard copy documentation. Hard copy documentation shall be provided by each registered or licensed individual who makes use of such system by one of the following methods:

(1) A hard copy printout of each day's prescription data.

(a) The printout shall include, at a minimum, the following data:

(i) Date of dispensing;

(ii) Prescription number;

(iii) Patient name;

(iv) Name, strength, and quantity of drug dispensed;

(v) Identification of the pharmacist or pharmacy personnel responsible for any activity described in paragraph (A) of this rule;

(vi) Identification of the pharmacy; and

(vii) Identification of controlled substances.

(b) The printout must be verified, dated, and signed by each individual responsible for any activity described in paragraph (A) of this rule. The printout must be verified and manually signed by the individual within a reasonable timeframe to ensure the accuracy of the record.

(c) If the printout is prepared at a location other than where the drug was dispensed, the printout must be provided to the licensed location within three business days of the date on which the drugs were dispensed. Such printouts must be verified and signed by each individual responsible for any activity described in paragraph (A) of this rule within twenty-four hours of the date the printout is received by the individual.

(d) The printout must be readily retrievable and maintained in chronological order in a separate file at the licensed location where the drug was dispensed for a period of three years from the date of dispensing.

(e) The signed printout may be stored electronically in accordance with paragraph (E) of this rule.

(2) A tamper evident log book.

(a) Each individual pharmacist involved in dispensing drugs must enter into a tamper evident log book the following data for each prescription dispensed:

(i) Date of dispensing;

(ii) Prescription number;

(iii) Patient name;

(iv) Name, strength and quantity of drug dispensed;

(v) Identification of the pharmacist and pharmacy personnel responsible for any activity described in paragraph (A) of this rule;

(vi) Identification of controlled substances.

(b) Each individual responsible for any activity described in paragraph (A) of this rule shall review this information at the end of each day, or at the end of the individual's shift, and must either:

(i) Manually sign a statement in the log book attesting to the fact that the prescription information entered into the computer that day and recorded in the log book has been reviewed by the individual and is correct as shown; or

(ii) Manually initial each entry of the log book to indicate that the prescription information entered into the computer that day and recorded in the log book has been reviewed by the individual and is correct as shown.

(c) The log book must be readily retrievable and maintained at the licensed location where the drug was dispensed for a period of three years from the date of dispensing.

(E) A signed printout that is maintained in accordance with paragraph (D) of this rule may be electronically created and maintained, provided the system creates and maintains the printout in accordance with the following:

(1) All information in the printout shall be scanned in full color (i.e. retains color information and/or color graphics in the document) via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(2) A record or image once created shall be unalterable but may be annotated as necessary so long as the original record or image is still available for review and the individual that made the annotation is noted;

(3) Contains security features to prevent unauthorized access to the records;

(4) Contains daily back-up functionality to protect against record loss.

(F) In addition to the immediate retrieval and production of prescription information required by paragraph (C) of this rule, an outpatient pharmacy that utilizes a computerized record keeping system shall comply with the following:

(1) Make readily retrievable the following information:

(a) An electronic record in a character-delimited or fixed-width ASCII text file or other mutually acceptable format that contains any requested data fields the pharmacy is responsible for maintaining pursuant to all federal and state laws, rules and regulations; and

(b) A hard copy printout sorted by any requested data fields that the pharmacy is responsible for maintaining pursuant to all federal and state laws, rules, and regulations.

(2) Make readily available upon request by an individual authorized by law to access such records any of the following:

(a) A printout; or

(b) An electronic record and a definition file describing the file layout and column width, if applicable.

(3) All computerized record keeping systems shall be able to capture records edited by authorized personnel and maintain an audit trail.

(G) In the event that a pharmacy utilizes a computerized record keeping system that experiences an outage, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of prescription orders. This auxiliary procedure must ensure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is recorded and retained. Nothing in this paragraph shall preclude a pharmacist from dispensing a refill if, in the exercise of the pharmacist's professional judgement, failure to dispense or sell the drug to the patient could result in harm to the health of the patient.

(H) Prescriptions entered into a computer system that are not dispensed shall meet all of the following requirements:

(1) The complete prescription information must be entered in the computer system;

(2) The information must appear in the patient's profile;

(3) There is positive identification of the person who is responsible for entering the prescription information into the system and the pharmacist responsible for verifying the prescription information in accordance with paragraph (A) of this rule;

(4) The prescription must be assigned a prescription number; and

(5) The original prescription is filed according to rule 4729:5-5-03 of the Administrative Code.

(I) Records shall be maintained for three years and made readily retrievable for all immunizations administered in accordance with section 4729.41 of the Revised Code and rules 4729:1-3-02 and 4729:2-3-03 of the Administrative Code and shall include the following information:

(1) Full name and address of the patient;

(2) Patient's date of birth or age;

(3) Patient's applicable allergy information;

(4) Date of administration;

(5) Name, strength, and dose of the immunization administered;

(6) Lot number and expiration date of the immunization;

(7) Route of administration;

(8) Location of the injection site;

(9) Positive identification of the administering pharmacist or the administering pharmacy intern and supervising pharmacist;

(10) Identification of the patient, parent, or legal guardian of the patient who gives informed consent to administer the immunization.

(J) Immunization records may be electronically created and maintained if done so in accordance with the standards set forth in paragraph (E) of this rule.

(K) A pharmacist may document the pharmacist's own administration of an immunization or an immunization administered by a pharmacy intern the pharmacist is personally supervising on a prescription form, which may be assigned a number for record keeping purposes.

(L) Records shall be maintained for three years and made readily retrievable for all dangerous drugs administered in accordance with section 4729.45 of the Revised Code and rule 4729:1-3-03 of the Administrative Code and shall include the following information:

(1) Full name and address of the patient;

(2) Patient's date of birth or age;

(3) Patient's applicable allergy information;

(4) Date of administration;

(5) Name, strength, and dose of the drug administered;

(6) Lot number and expiration date of the drug;

(7) Route of administration;

(8) Location of the injection site;

(9) Documentation of test results required prior to the administration of an opioid antagonist in accordance with rule 4729:1-3-03 of the Administrative Code;

(10) Required physician notification pursuant to rule 4729:1-3-03 of the Administrative Code;

(11) Positive identification of the administering pharmacist; and

(12) Identification of the person who provides permission to administer the dangerous drug pursuant to rule 4729:1-3-03 of the Administrative Code.

(M) Dangerous drug administration records may be electronically created and maintained if done so in accordance with the standards set forth in paragraph (E) of this rule.

Last updated July 21, 2026 at 4:06 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-05 Prescription format requirements.

(A) Except as provided in paragraph (E) of this rule, no pharmacist shall dispense dangerous drugs pursuant to a written outpatient prescription unless the following conditions are met:

(1) The prescription is issued in compliance with rule 4729:5-5-15 of the Administrative Code.

(2) If handwritten, typewritten, or computer-generated hard copy, there are no more than three non-controlled substance prescription orders per prescription form.

(3) If preprinted with multiple drug names or strength combinations:

(a) There are no controlled substances among the choices;

(b) There is only one prescription order selected per form.

(B) Except as provided in paragraph (E) of this rule, no pharmacist shall dispense controlled substances pursuant to a written outpatient prescription unless the following conditions are met:

(1) The prescription has been issued in compliance with rule 4729:5-5-15 of the Administrative Code.

(2) The prescription contains only one prescription order per prescription form, whether handwritten, typewritten, computer-generated hard copy, or preprinted.

(3) The quantity has been written both numerically and alphabetically.

(4) If preprinted, there is only one drug and strength combination printed on the form.

(C) A prescription for a controlled substance issued by a medical intern, resident, or fellow as described in rule 4729:5-1-02 of the Administrative Code may not be dispensed unless the prescription is issued in accordance with this rule and complies with the requirements for drug enforcement administration (D.E.A.) registration numbers for hospital and other institution employed prescribers pursuant to agency 4729 of the Administrative Code.

(D) A prescription for a controlled substance issued by a staff prescriber of a hospital or other institution may not be dispensed unless the prescription is issued in accordance with this rule and complies with either:

(1) The requirements for D.E.A. registration numbers for hospital or other institution employed prescribers pursuant to agency 4729 of the Administrative Code; or

(2) Includes the prescriber's D.E.A. registration number.

(E) For purposes of preprinted outpatient prescription forms for hospice care programs, the following conditions apply:

(1) Preprinted prescription forms may contain multiple orders on one form and the prescriber may select as many drug orders as necessary. Additional prescriptions may be manually added to the form.

(2) Preprinted forms shall not contain prescription orders for schedule II controlled substances. Schedule II controlled substances may be manually added to the preprinted forms and signed by the prescriber.

(3) The prescriber shall indicate on each preprinted form the drug orders authorized on the form by either:

(a) Manually indicating the total drug orders authorized on the form; or

(b) Manually initialing each drug order.

(4) All written drug orders must be signed by the prescriber.

(5) All signed prescriptions may be faxed from the prescriber or the hospice location to the pharmacy.

(6) At the direction of the prescriber, verbal drug orders may be transmitted to the pharmacy by the prescriber's agent, including a hospice nurse, except for schedule II controlled substances.

(7) All schedule II controlled substance prescriptions shall comply with 21 C.F.R. 1306.11 (3/31/2010).

Last updated May 19, 2026 at 4:58 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-06 Labeling of drugs dispensed on prescription.

(A) No drug may be dispensed by outpatient prescription unless a label is affixed to the container in which such drug is dispensed, and such label includes:

(1) The name or "doing business as" (DBA) name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license;

(2) The contact phone number of the dispensing pharmacy or a location where a pharmacist is employed or contracted by the dispensing pharmacy who has full access to the dispensing pharmacy's patient records;

(3) The full name of the patient for whom the drug is prescribed; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals;

(4) The full name of the prescriber or the first initial of the prescriber's first name and the full last name of the prescriber;

(5) Directions for use of the drug;

(6) The date of dispensing;

(7) Any cautions which may be required by federal or state law;

(8) The serial number of the prescription;

(9) The proprietary name, if any, or the generic name and the name of the distributor or national drug code of the drug dispensed, and the strength, if more than one strength of the drug is marketed. The dispensing pharmacist may omit the name and strength of the drug only if the prescriber specifically requests omission and such request is documented; and

(10) The quantity of drug dispensed.

(B) The term "affix" means the prescription label must be attached or fastened to the drug's container.

(C) A label meeting the requirements in paragraph (A) of this rule may be placed on the packaging of a commercially manufactured dangerous drug product.

Last updated April 2, 2024 at 9:04 AM

History

Effective: April 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-07 Patient profiles.

All outpatient pharmacies shall maintain a patient profile system which shall provide for immediate retrieval of information regarding those patients who have received prescriptions from the pharmacy.

(A) All patient profile systems shall maintain, at a minimum, the following data:

(1) The patient's data record, which shall contain all the following information:

(a) Full name of the patient for whom the drug is intended; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals.

(b) Residential address, including the physical street address and telephone number of the patient or owner.

(d) Patient's gender.

(e) A list of current patient-specific data consisting of at least the following, if made known to the pharmacist or agent of the pharmacist:

(i) Drug related allergies;

(ii) Previous drug reactions;

(iii) History of or active chronic conditions or disease states; and

(iv) Other drugs, including nonprescription drugs, devices, and nutritional supplements used on a routine basis.

(f) The pharmacist's comments relevant to the patient's drug therapy, including any other necessary information unique to the specific patient or drug.

(2) The patient's drug therapy record, which shall contain the following information for all prescriptions dispensed by the pharmacy within the last twelve months:

(a) The original prescription number.

(b) Date of issuance of the original prescription by the prescriber.

(d) The prescriber's credential (MD, DDS, DVM, etc.), if indicated on the prescription.

(e) Directions for use.

(f) The brand name, if any, or the generic name and the name of the manufacturer or distributor or national drug code of the drug or device dispensed.

(g) The strength, dosage form, and quantity of the drug or device dispensed.

(h) The prescriber's federal drug enforcement administration registration number, if applicable.

(i) The total number of refills authorized by the prescriber.

(j) The date of dispensing.

(k) The refill history of the prescription, including all the following:

(i) The prescription number;

(ii) The brand name, if any, or the generic name and the name of the manufacturer or distributor or national drug code of the drug or device dispensed;

(iii) The date(s) of dispensing; and

(iv) The quantity dispensed.

(B) A pharmacist or an agent of the pharmacist shall make a reasonable effort to obtain a patient's medical history necessary to conduct a prospective drug utilization review. An agent of the pharmacist described in this paragraph shall be limited to the following persons: a pharmacy intern, certified pharmacy technician, registered pharmacy technician or pharmacy technician trainee.

(C) The patient profile shall be maintained for a period of not less than one year from the date of the last entry in the profile record. This record may be a hard copy or maintained as a part of computerized system.

Last updated May 19, 2026 at 4:58 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-08 Prospective drug utilization review.

(A) Prior to dispensing any prescription, a pharmacist shall review the patient profile for the purpose of identifying the following:

(1) Over-utilization or under-utilization;

(2) Therapeutic duplication;

(3) Drug-disease state contraindications;

(4) Drug-drug interactions;

(5) Incorrect drug dosage;

(6) Drug-allergy interactions;

(7) Abuse/misuse;

(8) Inappropriate duration of drug treatment; and

(9) Food-nutritional supplements-drug interactions.

(B) Upon identifying any issue listed in paragraph (A) of this rule, a pharmacist, using professional judgment, shall take appropriate steps to avoid or resolve the potential problem. These steps may include, but shall not be limited to, the following:

(1) Requesting and reviewing an OARRS report or another state's prescription drug monitoring report;

(2) Consulting with the prescriber; or

(3) Counseling the patient.

(C) Prospective drug utilization review shall be performed using predetermined standards consistent with, but not limited to, any of the following:

(1) Peer-reviewed medical literature (i.e. scientific, medical, and pharmaceutical publications in which original manuscripts are rejected or published only after having been critically reviewed by unbiased independent experts);

(2) American hospital formulary service drug information; and

(3) United States pharmacopeia drug information.

(D) Prior to dispensing an outpatient prescription for a controlled substance dangerous drug or a drug containing gabapentin, at a minimum, a pharmacist shall request and review an OARRS report covering at least a one year time period in any of the following circumstances:

(1) A patient adds a new or different controlled substance dangerous drug or a drug containing gabapentin to the patient's therapy that was not previously included;

(2) An OARRS report has not been reviewed for that patient during the preceding twelve months, as indicated in the patient profile;

(3) A prescriber is located outside the usual pharmacy geographic area;

(4) A patient is from outside the usual pharmacy geographic area;

(5) A pharmacist has reason to believe the patient has received prescriptions for controlled substance dangerous drugs or a drug containing gabapentin from more than one prescriber in the preceding three months, unless the prescriptions are from prescribers who practice at the same physical location;

(6) Patient is exhibiting signs of potential abuse or diversion. This includes, but is not limited to, over-utilization, early refills, appears overly sedated or intoxicated upon presenting a prescription for a controlled substance dangerous drug, or an unfamiliar patient requesting a reportable drug by specific name, street name, color, or identifying marks.

(E) In the event an OARRS report is not immediately available, the pharmacist shall use professional judgment in determining whether it is appropriate and in the patient's best interest to dispense the prescription prior to reviewing a report.

(F) A pharmacist may use a delegate licensed or registered in accordance with Chapter 4729. of the Revised Code to request an OARRS report.

(G) Based upon information obtained during a prospective drug utilization review, a pharmacist shall use professional judgment when making a determination about the legitimacy of a prescription. A pharmacist shall not dispense a prescription of doubtful, questionable, or suspicious origin.

Last updated May 19, 2026 at 4:58 PM

History

Effective: November 15, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-09 Patient counseling.

(A) A pharmacist or the pharmacist's designee shall verbally offer to provide the service of counseling pursuant to paragraph (B) of this rule to a patient or caregiver whenever any prescription, new or refill, is dispensed. A pharmacist or pharmacy intern under the personal supervision of a pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses the offer of counseling or does not respond to the written offer to counsel. If the patient or caregiver is not physically present, the offer to counsel shall be made by telephone or in writing on a separate document accompanying the dispensed drug or incorporated as part of documentation, in a conspicuous manner, that is included with the dispensed drug. A written offer to counsel shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service must be available at no cost to the pharmacy's primary patient population.

(B) In the event a patient or caregiver accepts an offer to counsel or requests counseling, a pharmacist, or a pharmacy intern under the personal supervision of a pharmacist, shall counsel the patient or caregiver. Such counseling may include, but is not limited to, the following:

(1) The name and description of the drug;

(2) The dosage form, dose, strength, frequency, route of administration, and duration of drug therapy;

(3) The intended use of the drug and the expected action;

(4) Special directions and precautions for preparation, administration, handling, storage, disposal, and use by the patient;

(5) Common adverse effects or interactions and therapeutic contraindications that may occur, including possible methods to avoid them, and the action required if they occur;

(6) Techniques for self-monitoring drug therapy;

(7) Proper storage and disposal;

(8) Prescription refill information;

(9) Action to be taken in the event of a missed dose; and

(10) The pharmacist's comments relevant to the patient's drug therapy, including other necessary information unique to the patient or drug.

(C) Other forms of information may be used when appropriate to supplement the counseling by the pharmacist or intern. Examples of forms that may be used include, but are not limited to, drug product information leaflets, pictograph labels, and video programs.

(D) Notwithstanding any other rule of agency 4729 of the Administrative Code, "personal supervision," as used in paragraph (B) of this rule, means that a pharmacist is on the premises at all times and is aware of all counseling activities performed by the pharmacy intern. A pharmacist who has accepted responsibility for the supervision and training of a pharmacy intern is responsible for all acts performed by the pharmacy intern working under the pharmacist's supervision.

Last updated May 19, 2026 at 4:58 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-10 Manner of processing a prescription.

(A) A prescription, to be valid, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of the prescriber's professional practice. The responsibility for the proper prescribing is upon the prescriber, but a corresponding responsibility rests with the pharmacist who dispenses the prescription. An order purporting to be a prescription issued not in the usual course of bona fide treatment of a patient is not a prescription and the person knowingly dispensing such a purported prescription, as well as the person issuing it, shall be subject to the penalties of law.

(B) A pharmacist dispensing an outpatient prescription shall comply with the requirements of this chapter, including, but not limited to, the following:

(1) Ensure that patient information is profiled pursuant to rule 4729:5-5-07 of the Administrative Code;

(2) Perform prospective drug utilization review pursuant to rule 4729:5-5-08 of the Administrative Code; and

(3) Ensure that the drug is labeled pursuant to rule 4729:5-5-06 of the Administrative Code.

(1) The front of hard copy prescriptions for controlled substance dangerous drugs shall be clearly notated to indicate receipt by the pharmacy in a manner that does not destroy any of the original information contained on the prescription but prevents the unauthorized duplication of the prescription.

(2) When a pharmacist dispenses a drug pursuant to an original prescription, the pharmacist must record the date of such dispensing and the pharmacist's positive identification.

(3) When a pharmacist dispenses a drug pursuant to an authorized refill of a prescription, the pharmacist must record the date of such dispensing and the pharmacist's positive identification.

(D) Oral prescriptions:

(1) A pharmacist shall make a record of the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent. The pharmacist is responsible for ensuring the validity of the source of the oral prescription.

(2) Upon receiving a prescription from a recording device or voice mail service, a pharmacist shall transcribe the information. The pharmacist must document on the original prescription the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent. The pharmacist is responsible for ensuring the validity of the prescription removed from the recording device or voice mail service.

(3) A licensed pharmacy intern may receive telephone prescriptions and remove prescriptions from a recording device or voice mail service if the pharmacist on duty who is personally supervising the activity of the intern determines that the intern is competent to perform this function.

(a) The intern shall immediately transcribe the prescription, document the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent and shall review the prescription with the pharmacist on duty. Prior to dispensing, positive identification of the intern and the pharmacist on duty shall be recorded to identify the responsibility for the receipt of the oral order.

(b) The pharmacist on duty is responsible for the accuracy of the prescription.

(c) The pharmacist on duty must be immediately available to answer questions or discuss the prescription with the prescriber or the prescriber's agent.

(4) A certified pharmacy technician may receive telephone prescriptions and remove prescriptions from a recording device or voice mail service for non-controlled drugs in accordance with rule 4729:3-3-04 of the Administrative Code.

(E) Facsimile prescriptions:

A facsimile shall only be valid as a prescription if a pharmacy retains a printed copy of a facsimile prescription or an electronic copy of the facsimile prescription in accordance with rule 4729:5-5-03 of the Administrative Code. The facsimile prescription shall comply with the requirements of rule 4729:5-3-11 of the Administrative Code.

(F) Electronic prescriptions:

(1) A pharmacy receiving electronic prescriptions directly into its computer system shall ensure original prescription information received from the prescriber is maintained in accordance with rule 4729:5-5-03 of the Administrative Code.

(2) A pharmacy computer system receiving electronic prescriptions shall:

(a) Comply with the applicable provisions of 21 C.F.R. 1311 (05/01/19); and

(b) Have the capability to receive an ICD-10-CM medical diagnosis code for all controlled substance prescriptions pursuant to rule 4729:5-5-15 of the Administrative Code.

(G) Except as provided for in section 4729.46 of the Revised Code, a pharmacist shall not dispense a dangerous drug for the first time beyond six months from the date of issuance of a prescription.

(H) The quantity prescribed shall be considered the quantity dispensed, unless the quantity dispensed meets any of the following:

(1) If the dispensed prescription is less than the quantity prescribed, the pharmacist shall note the quantity dispensed on the original prescription or within a computerized recordkeeping system.

(2) If the quantity dispensed on a prescription is greater than the quantity prescribed, the pharmacist shall record on the original prescription or within a computerized recordkeeping system the name of the authorizing prescriber, the full name of the agent of the prescriber, if applicable, the quantity authorized to be dispensed, and the date that the authorization was obtained.

(3) A prescription dispensed in accordance with section 4729.40 of the Revised Code. The pharmacist shall note the quantity dispensed on the original prescription or within a computerized recordkeeping system.

(I) Where a prescription is written using a generic name, or where the pharmacist dispenses an equivalent drug product pursuant to the provisions of sections 4729.38 and 4729.381 of the Revised Code, the brand name or drug name and name of the manufacturer or distributor of the drug or the national drug code (NDC) number of the drug dispensed must be recorded in the record of dispensing by the pharmacist.

(J)

(1) A prescription issued by a prescriber who experiences a change of status, as defined in paragraph (J)(2) of this rule, that precludes a continued prescriber-patient relationship may be dispensed by a pharmacist in accordance with the following:

(a) In the exercise of the pharmacist's professional judgment:

(i) The drug is essential to sustain the life of the patient or continue therapy for a chronic condition of the patient; or

(ii) Failure to dispense the drug to the patient could result in harm to the health of the patient.

(b) The prescription was issued prior to the prescriber's change of status, as defined in paragraph (J)(2) of this rule, and in accordance with all applicable provisions of state and federal laws, rules and regulations.

(c) For a non-controlled substance prescription, a pharmacist may dispense up to a thirty-day supply as provided in the prescription or, if the standard unit of dispensing for the drug exceeds a thirty-day supply, the amount of the drug dispensed shall not exceed the standard unit of dispensing. The pharmacist shall exercise professional judgment in determining the amount of the drug to be dispensed.

(d) For a controlled substance prescription, a pharmacist may dispense up to a seventy-two-hour supply as provided in the prescription. The pharmacist shall exercise professional judgment in determining the amount of the drug to be dispensed.

(2) A change of status includes, but is not limited to, the following: death, incapacity, suspension, surrender or revocation of the prescriber's license or registration, or permanent relocation.

(3) A prescription for a dangerous drug dispensed in accordance with paragraph (J)(1) of this rule is considered void after the initial dispensing and may not be dispensed again. Following the initial dispensing of the drug, a pharmacist shall utilize a manual or electronic method for invalidating the prescription to prevent further dispensing.

Last updated May 19, 2026 at 4:58 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-11 Prescription copy.

(A) An outpatient pharmacy may send or receive copies of prescriptions in accordance with the following:

(1) Copies of prescriptions shall be transferred only between pharmacists, except as follows:

(a) Pharmacy interns in accordance with paragraph (G) of this rule; and

(b) Certified pharmacy technicians in accordance with rule 4729:3-3-04 of the Administrative Code.

(2) Copies of prescriptions for controlled substances shall be communicated directly between two pharmacists and, except as provided in paragraph (A)(3) of this rule, shall be transferred only one time.

(3) Pharmacies electronically sharing a real time, online database may transfer a controlled substance prescription up to the maximum number of refills permitted by law and the prescriber's authorization.

(4) The copy transferred shall be an exact duplicate of the original prescription, except that it shall also include the following:

(a) Serial prescription number assigned to the prescription;

(b) Name, address and, if a controlled substance prescription, the drug enforcement administration (D.E.A.) registration number of the pharmacy transferring the copy;

(d) Date of last refill;

(e) Number of valid refills or quantity remaining; and

(f) The full name of the transferring pharmacist or, if transferred by a pharmacy intern or certified pharmacy technician, the full name of the transferring pharmacy intern or certified pharmacy technician and the pharmacist on duty who is supervising the activity of the intern or technician.

(5) A pharmacist transferring a copy of a controlled substance prescription shall:

(a) Write the word "VOID" on the face of the invalidated prescription in a manner that does not destroy any of the original information contained on the prescription; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record.

(b) Record on the reverse of the invalidated prescription the name, address, and the D.E.A. registration number of the pharmacy to which it was transferred and the first and last name of the pharmacist receiving the prescription information; for electronic prescriptions, such information must be added to the prescription record.

(d) Ensure copies of controlled substance prescriptions may only be transferred if the prescription record in the system is invalidated to prevent further dispensing at the original pharmacy.

(6) A pharmacist, pharmacy intern, or certified pharmacy technician transferring a copy of a non-controlled substance prescription shall:

(a) Utilize a manual or electronic method for invalidating the prescription to prevent further dispensing at the original pharmacy.

(b) Record the name and address of the pharmacy to which it was transferred.

(c) If transferred orally, the first and last name of the pharmacist or authorized pharmacy personnel receiving the prescription information.

(d) Record the date of the transfer and the name of the pharmacist, pharmacy intern, or certified pharmacy technician transferring the information.

(7) A pharmacist, pharmacy intern, or certified pharmacy technician receiving a copy of a prescription must comply with the following:

(a) Exercise reasonable diligence to determine the validity of the copy.

(b) Transcribe an oral prescription by recording all the information transferred. The oral prescription shall include all information required in paragraph (A)(4) of this rule and the pharmacist, pharmacy intern, or certified pharmacy technician shall write the word "transfer" on the face of the prescription or indicate the prescription was transferred within a computerized record keeping system.

(d) Prior to dispensing, positive identification of the receiving pharmacist shall be recorded to identify who is responsible for the receipt of the copy. For pharmacy interns, positive identification shall be documented in accordance with paragraph (G)(5) of this rule. For certified pharmacy technicians, positive identification shall be documented in accordance with rule 4729:3-3-04 of the Administrative Code.

(B) A prescription copy may be transferred electronically between pharmacies if the pharmacies are accessing the same prescription records in a centralized database or the pharmacies' computers are linked in any other manner. The computer systems must be able to comply with the requirements of paragraphs (A)(4) and (A)(5)(d) of this rule. This shall include invalidation of the prescription record in the system to prevent further dispensing at the original pharmacy and, if a controlled substance prescription, the canceling of the original written prescription as required in paragraphs (A)(5)(a) and (A)(5)(b) of this rule.

(C) A prescription copy may be transferred by the use of a facsimile machine. A facsimile shall be considered a copy of the prescription if it meets the requirements of paragraph (A) of this rule, including invalidation of the original prescription. Facsimile copies must be recorded in writing pursuant to section 4729.37 of the Revised Code or stored in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.

(D) Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for use by the patient.

(1) If the pharmacy is not able to provide the medication when needed by the patient pursuant to an authorized refill, the pharmacy shall, upon the request of the patient or patient's caregiver, transfer the prescription information to a pharmacy designated by the patient.

(2) Unless otherwise prohibited by law, no pharmacy shall refuse to transfer information about a prescription to another pharmacy when requested by the patient or patient's caregiver. Prescription information shall be transferred in accordance with this rule as soon as possible to ensure that the patient's drug therapy is not interrupted.

(3) A prescription may only be transferred upon the request or consent of the patient or patient's caregiver.

(E) Prescriptions entered into a computer system but not dispensed shall be transferred to another pharmacy, at the request of the patient or patient's caregiver, if all of the following conditions are met:

(1) The complete prescription information has been entered into the computer system.

(2) The information is displayed on the patient's profile.

(3) There is positive identification of the individual responsible for entering the prescription information into the system and the pharmacist responsible for verification of the information entered into the system.

(4) The original prescription is filed in accordance with rule 4729:5-5-03 of the Administrative Code.

(5) The prescription is assigned a prescription number.

(6) All requirements of this rule are met for the transfer of the prescription.

(7) The transfer is conducted in accordance with all state and federal laws, rules and regulations.

(8) A pharmacist may transfer an unfilled electronic prescription for a controlled substance to another pharmacist in accordance regulations or policies adopted by the United States drug enforcement administration.

(F) Transfer of prescription information between two pharmacies which are accessing the same real time, online database pursuant to the operation of a licensed central fill pharmacy shall not be considered a prescription copy and, therefore, is not subject to the requirements of this rule.

(G) A licensed pharmacy intern may send or receive copies of prescriptions in accordance with the following:

(1) The pharmacist on duty who is supervising the activity of the intern determines if the intern is competent to send or receive a prescription copy.

(2) The pharmacist on duty who is supervising the activity of the intern is responsible for the accuracy of a prescription copy that is sent or received by an intern.

(3) The pharmacist on duty must be immediately available to answer questions or discuss the prescription copy that is sent or received by an intern.

(4) The pharmacist or intern receiving a prescription copy from an intern must document the full names of the sending intern and the intern's supervising pharmacist.

(5) The intern receiving a prescription copy shall immediately transcribe the prescription and shall review the prescription with the pharmacist on duty. Prior to dispensing, positive identification of the intern and the supervising pharmacist on duty shall be recorded to identify who is responsible for the receipt of the copy.

(6) The pharmacist or intern sending a prescription copy to an intern must document the full names of the receiving intern and the pharmacist on duty.

(7) The intern shall not send or receive a prescription copy for a controlled substance.

(8) The intern and the pharmacist on duty shall comply with all the requirements of this rule.

Last updated June 11, 2026 at 11:14 AM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-12 Partial dispensing of schedule II controlled substances.

(A) A valid prescription for a schedule II controlled substance may be partially dispensed as follows:

(1) For a terminally ill patient or a patient residing in a long-term care facility, compliance with 21 C.F.R. 1306.13 (03/31/2010).

(2) For a patient who is not terminally ill or residing in a long-term care facility, the following must be observed:

(a) The partial dispensing shall be requested by the patient or the prescriber that issued the prescription;

(b) The total quantity dispensed in all partial dispensings shall not exceed the total quantity prescribed; and

(c) The remaining portions of a partially dispensed schedule II controlled substance prescription shall be filled not later than thirty days after the date on which the prescription is written.

(B) The partial dispensing of a schedule II controlled substance prescription can only occur at the pharmacy where the original prescription is on file.

(C) At the time of partial dispensing of a schedule II controlled substance, the following must be noted on the back of the original prescription or within a computerized record keeping system pursuant to rule 4729:5-5-04 of the Administrative Code: the date dispensed, quantity dispensed, remaining quantity authorized to be dispensed, prescription number of the partial dispensing if different, and the manual initials or other form of positive identification of the dispensing pharmacist.

(D) If a computerized record keeping system is being used and the system will not permit refills of schedule II controlled substances, a new prescription number for the partial dispensing must be assigned.

(1) A notation must also be made in the record keeping system that identifies the new prescription number as a partial dispensing and provides the serial number of the original prescription.

(2) A prescription bearing the new serial number must be placed in the schedule II file. The prescription for each partial filling must also show the serial number of the original prescription and all previous partial fills.

Last updated May 19, 2026 at 4:58 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-13 Serial numbering of prescriptions.

All outpatient prescriptions must be serially numbered when entered into a computer system or when dispensed under a manual system.

(A) The serial number must appear on the original prescription.

(B) There must be a complete accounting of all numbers used in the serial numbering system.

(C) All prescriptions that cannot be refilled, either because of the dispensing of all refills or the length of time since issuance, shall be assigned a new serial number upon an authorization for additional dispensing by a prescriber or prescriber's agent.

Last updated July 10, 2026 at 11:19 AM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-15 Manner of issuance of a prescription.

(B) All outpatient prescriptions issued by a prescriber shall:

(1) Be dated as of and on the day when issued.

(2) Contain the manually printed, typewritten, or preprinted full name, professional title, and address of the prescriber. The prescriber's address shall include the physical address of the prescriber's practice location.

(3) Indicate a telephone number where the prescriber can be contacted during normal business hours.

(4) Indicate the full name and residential address of the patient; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals. The patient or owner's residential address shall include a physical street address.

(5) Indicate the drug name and strength.

(6) Indicate the quantity to dispense.

(7) Indicate the appropriate and explicit directions for use.

(8) Specify the number of times or the period of time for which the prescription may be refilled. If no such authorization is given, the prescription may not be refilled except in accordance with section 4729.281 of the Revised Code.

(a) Prescriptions for non-controlled substance dangerous drugs bearing "PRN," "Ad lib," or other similar prescription refill designation permitting the pharmacist to refill the prescription as needed by the patient, shall be refilled only in keeping with the number of doses ordered and according to the directions for use, and, in no instance, shall such prescription be refilled beyond one year from the date of issue. The prescription shall not be refilled out of context with the dosage schedule indicated in the directions for use unless specifically authorized by the prescriber.

(b) Prescriptions for controlled substance dangerous drugs bearing "PRN," "Ad lib," or other similar prescription refill designation are not considered a valid refill authorization.

(9) Not authorize any refills for schedule II controlled substances.

(10) Authorize refills for schedules III and IV controlled substances only as permitted by section 3719.05 of the Revised Code.

(11) Not authorize a refill beyond one year from the date of issuance for schedule V controlled substances and for dangerous drugs that are not controlled substances.

(12) Identify the trade name or generic name of the drug(s) in a compounded prescription.

(13) Not be coded in such a manner that it cannot be dispensed by any pharmacy of the patient's choice.

(14) For a controlled substance:

(a) Indicate the drug enforcement administration registration number of the prescriber pursuant to 21 CFR 1306.05 (3/31/2010).

(b) Except for veterinarians licensed pursuant to Chapter 4741. of the Revised Code, indicate either:

(i) The ICD-10-CM medical diagnosis code of the primary disease or condition that the controlled substance is being used to treat. The code shall, at a minimum, include the first four alphanumeric characters of the ICD-10-CM medical diagnosis code, sometimes referred to as the category and the etiology (ex. M 16.5).

(ii) For dentists licensed pursuant to Chapter 4715. of the Revised Code, the Code on Dental Procedures and Nomenclature (CDT Code), as published by the American dental association, of the dental treatment requiring the controlled substance prescription.

(15) Except for veterinarians licensed under Chapter 4741. of the Revised Code, for all controlled substances and products containing gabapentin: indicate the prescriber's intended days' supply of the prescription.

(16) For a managing pharmacist acting as an agent of a physician pursuant to section 4729.39 of the Revised Code and Chapter 4729:1-6 of the Administrative Code, the prescription shall include the full name of the managing pharmacist.

(17) Be issued in compliance with all applicable federal and Ohio laws, rules, and regulations.

(C) Failure of a prescription to contain the requirements set forth in paragraphs (B)(14)(b) and (B)(15) of this rule or of the pharmacist to obtain the information set forth in paragraphs (B)(14)(b) and (B)(15) of this rule shall not render the prescription, if dispensed in good faith, to be invalid.

(D) All prescriptions issued on paper to a patient by a prescriber shall be:

(1) Manually signed on the day issued by the prescriber in the same manner as the prescriber would sign a check or legal document.

(2) Issued in compliance with rule 4729:5-5-05 of the Administrative Code.

(E) When forms are used that create multiple copies of a prescription issued to a patient by a prescriber, the original prescription that includes the actual signature of the prescriber must be issued to the patient for dispensing by a pharmacist.

(F) Pursuant to section 4729.38 of the Revised Code, a pharmacist shall not select a generically equivalent drug or interchangeable biological product if either of the following applies:

(1) In the case of a written or electronic prescription, including a computer- generated prescription, the prescriber handwrites or actively causes to display on the prescription "dispense as written," "D.A.W.," "do not substitute," "brand medically necessary," or any other statement or numerical code that indicates the prescriber's intent to prevent substitution. Such a designation shall not be preprinted or stamped on the prescription, but a reminder to the prescriber of the designation procedure may be preprinted or displayed on the prescription form or electronic system the prescriber uses to issue the prescription.

(2) In the case of an oral prescription, the prescriber or the prescriber's agent specifies that the drug as prescribed is medically necessary or otherwise indicates the prescriber's intent to prevent substitution.

(G) Pursuant to section 4729.40 of the Revised Code, a pharmacist shall not dispense a quantity or amount of drug that varies from the quantity or amount of the drug that otherwise would be dispensed unless all the conditions are met in accordance with that section and either of the following applies:

(1) The prescriber includes "dispense as written" or another phrase having a similar meaning on the prescription. Such a designation shall not be preprinted or stamped on the prescription, but a reminder to the prescriber of the designation procedure may be preprinted or displayed on the prescription form or electronic system the prescriber uses to issue the prescription.

(2) When issuing a prescription electronically or orally, the prescriber specifies that the quantity or amount of the drug to be dispensed may not vary from the quantity or amount specified in the prescription.

(H) Pursuant to section 4729.382 of the Revised Code, a pharmacist shall not make the substitution of an epinephrine autoinjector if either of the following applies to the prescription:

(1) In the case of a written or electronic prescription, including a computer-generated prescription, the prescriber handwrites or actively causes to display on the prescription "dispense as written," "D.A.W.," "do not substitute," "medically necessary as prescribed," or any other statement or numerical code that indicates the prescriber's intent to prevent substitution. Such a designation shall not be preprinted or stamped on the prescription, but a reminder to the prescriber of the designation procedure may be preprinted or displayed on the prescription form or electronic system the prescriber uses to issue the prescription.

(2) In the case of an oral prescription, the prescriber specifies that the epinephrine autoinjector as prescribed is medically necessary or otherwise indicates the prescriber's intent to prevent substitution.

(I) A patient or patient's caregiver shall have the exclusive right to freedom of choice for any pharmacy to dispense prescriptions.

(J) A pharmacist may dispense a prescription from a prescriber practicing outside of Ohio, if all the following apply:

(1) The prescriber who issued the prescription would ordinarily be entitled to issue prescriptions under Ohio law and the state where the prescription was issued;

(2) The prescription meets all the requirements of this rule, including whether the prescription is for a legitimate medical purpose in accordance with paragraph (A) of this rule.

(3) The prescription is transmitted in accordance with rule 4729:5-3-11 of the Administrative Code; and

(4) For a controlled substance prescription, the prescriber holds a valid drug enforcement administration registration number in the state of origin of the prescription.

Last updated January 6, 2026 at 2:09 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-16 Pharmacist modifications to a prescription.

(A) For a schedule II controlled substance prescription:

(1) A pharmacist shall not make changes to the drug prescribed, except for substitution permitted by law, the prescriber's signature, or the patient's name.

(2) Any other modification, except for substitution permitted by law, may only be made after consultation with and agreement of the prescriber.

(B) For a schedule III-V controlled substance prescription:

(1) Except as provided for in paragraph (D) of this rule, a pharmacist shall not make changes to the drug prescribed, except for substitution permitted by law, the prescriber's signature, or the patient's name.

(2) Any other modification, except for substitution permitted by law, may only be made after consultation with and agreement of the prescriber or the prescriber's agent.

(1) Except as provided for in paragraphs (D) and (E) of this rule, a pharmacist shall not make changes to the drug prescribed, except for substitution permitted by law, the prescriber's signature, or the patient's name.

(2) Any other modification, except for substitution permitted by law or in accordance with paragraph (E) of this rule, may only be made after consultation with and agreement of the prescriber or the prescriber's agent.

(D) Except for a schedule II controlled substance prescription, a pharmacist may correct a patient's name on a prescription after consultation with and agreement of the prescriber or the prescriber's agent.

(E) For a non-controlled substance prescription, a pharmacist may change the dosage form, drug strength, drug quantity, and directions for use without consultation with and agreement of the prescriber or agent of the prescriber in accordance with the following:

(1) The drug selected must be the same drug indicated on the prescription;

(2) The drug selected must have the same frequency and duration of therapy as the drug indicated on the prescription;

(3) The prescription is for a human patient;

(4) No modifications shall be made pursuant to this paragraph if "dispense as written" or another phrase or indicator having a similar meaning is indicated on the prescription;

(5) The pharmacist who selects the drug to be dispensed pursuant to this paragraph shall assume the same responsibility for selecting the dispensed drug as would be incurred in filling a prescription for a drug using the prescribed form; and

(6) The pharmacist shall not substitute between long-acting and short-acting forms of the drug.

(F) A pharmacist may dispense a quantity of a drug in a manner that varies from the prescription in accordance with paragraph (H) of rule 4729:5-5-10 of the Administrative Code or rule 4729:5-5-12 of the Administrative Code and all applicable federal and state laws, rules, and regulations.

(G) All consultations and corresponding changes performed in accordance with this rule shall be noted by the pharmacist on the prescription or in the patient's profile and shall be communicated to the patient or patient's caregiver.

Last updated May 19, 2026 at 4:58 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-17 Drugs repackaged or relabeled by a pharmacy.

(A) As used in this rule, "repackaging" means the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug. Repackaging also includes the act of placing the contents of multiple containers (e.g., vials) of the same finished drug product into one container, as long as the container does not include other ingredients. If a drug is manipulated in any other way, including if the drug is reconstituted, diluted, mixed, or combined with another ingredient, that act is not considered repackaging.

(B) The following rule applies to dangerous drugs repackaged by an outpatient pharmacy. The rule does not apply to any of the following:

(1) Repackaging drug products for use in animals;

(2) Repackaging non-dangerous drug products;

(3) Radiopharmaceuticals as defined in Chapter 4729:5-6 of the Administrative Code;

(4) Repackaging conducted by outsourcing facilities or repackagers licensed in accordance with section 4729.52 of the Revised Code;

(5) Removing a drug product from the original container at the point of care (e.g., patient's bedside) for immediate administration to a single patient after receipt of a valid patient-specific prescription or order for that patient (e.g., drawing up a syringe to administer directly to the patient);

(6) Upon receipt of a valid patient-specific prescription or medication order, a licensed pharmacy removing from one container the quantity of non-sterile drug products (e.g., oral dosage forms) necessary to fill the prescription and placing it in a different container to dispense directly to the patient; and

(7) Investigational new drugs being studied under an investigational new drug application.

(1) "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities" guidance issued by the United States food and drug administration (January 2017) and any other subsequent repackaging guidance issued by the food and drug administration that is approved by the board;

(2) For sterile compounded drug preparations, United States pharmacopeia chapter <797> as referenced in rule 4729:7-1-01 of the Administrative Code.

(D) Labels of drugs repackaged by and stored within a pharmacy prior to being dispensed shall contain, but not be limited to, the following:

(1) Name of drug, strength, and dosage form;

(2) National drug code or universal product code, if applicable, which may be embedded in a bar code or quick response (QR) code on the label;

(3) The identification of the repackager by name or by the final seven digits of the terminal distributor of dangerous drugs license number;

(4) Pharmacy control number;

(5) The beyond-use date of the repackaged drug in accordance with the guidance listed in paragraph (C) of this rule.

(E) All drugs dispensed for outpatient use shall also be labeled in accordance with rule 4729:5-5-06 of the Administrative Code.

(F) A record of all drugs repackaged and stored within a pharmacy prior to being dispensed shall be kept in a readily retrievable manner for at least three years or one year past manufacturer's expiration date, whichever is greater. This record shall include the following:

(1) Name of drug, strength, dosage form, and quantity;

(2) National drug code or universal product code, if applicable, which may be embedded in a bar code or quick response (QR) code on the label;

(3) Manufacturer's or distributor's control number;

(4) Manufacturer's or distributor's name, if a generic drug is used;

(5) Pharmacy control number;

(6) Manufacturer's or distributor's expiration date;

(7) The pharmacy's beyond-use date in accordance with the guidance listed in paragraph (C) of this rule;

(8) The positive identification of the individual responsible for the repackaging of the drug; and

(9) The positive identification of the pharmacist conducting the final verification of the repackaged drug to confirm the accuracy of the drug and conformity to the requirements of this rule prior to dispensing or distribution.

(G) A pharmacy that uses supplemental labels that contain a bar code or QR code for the purpose of identifying a repackaged drug shall capture the positive identification of the pharmacist responsible for the following:

(1) Association of the bar code to the drug product; and

(2) Association of the label to the drug product.

Last updated July 10, 2026 at 11:19 AM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-18 Dispensing customized patient medication packages by an outpatient pharmacy.

In lieu of dispensing two or more dangerous drugs in separate containers, a pharmacist practicing at an outpatient pharmacy may dispense a customized patient medication package. A customized patient medication package is a package for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms that complies with the following requirements:

(A) The package is designed, or each container is labeled, to indicate the day and time or period of time when the contents within each container are to be taken by the patient.

(B) The number of drugs placed in each container cannot exceed the capability of the container to prevent damage to the dosage forms.

(D) The labels must be of sufficient size to properly and clearly label a ninety-day or less supply with all information required in accordance with this chapter of the Administrative Code, including the use of accessory labels.

(E) The package must include an expiration date or beyond-use date, which shall not exceed the expiration date on the manufacturer's container or six months from the date the drug was originally packaged, whichever date is earlier. If multiple manufacturer containers are used, the expiration date shall not exceed the expiration date on the manufacturer's container that will expire first or six months from the date the drug was originally repackaged, whichever date is earlier.

(F) Dangerous drugs which have been dispensed in a customized patient medication package may only be returned to stock or re-dispensed in accordance with all the following:

(1) The drugs have not been in the possession of the ultimate user; and

(2) The drugs have not been placed in the same container with another dangerous drug (i.e. did not come into direct contact with a different drug within the same container).

(G) The containers of a package are sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

(H) Any pharmacy dispensing customized patient medication packages in accordance with this rule must implement policies and procedures that will exclude drugs having any of the following characteristics from such packaging:

(1) The U.S.P. monograph or official labeling requires dispensing in the original container, unless there is documentation from the manufacturer stating otherwise;

(2) The drugs or dosage forms are incompatible with packaging components or each other;

(3) The drugs are therapeutically incompatible when administered simultaneously;

(4) The drugs require special packaging.

Last updated October 1, 2024 at 9:20 AM

History

Effective: October 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-19 Central fill pharmacies.

(A) As used in this chapter:

(1) "Central fill pharmacy" means a pharmacy licensed as a terminal distributor of dangerous drugs acting as an agent of an originating pharmacy to fill or refill a prescription. A central fill pharmacy may also be the originating pharmacy pursuant to paragraph (D) of this rule.

(2) "Originating pharmacy" means an outpatient pharmacy licensed as a terminal distributor of dangerous drugs that uses a central fill pharmacy to fill or refill a prescription.

(B) A central fill pharmacy and originating pharmacy may process a request for the filling or refilling of a prescription received by an originating pharmacy only pursuant to the following requirements:

(1) The central fill pharmacy either has the same owner as the originating pharmacy or has a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract in compliance with federal and state law. The contract shall expressly state who is responsible for performing the patient counseling requirements in accordance with rule 4729:5-5-09 of the Administrative Code.

(2) The central fill pharmacy shall maintain a record of all originating pharmacies, including name, address, terminal distributor of dangerous drugs license number, and, if applicable, drug enforcement administration registration number, for which it processes a request for the filling or refilling of a prescription received by the originating pharmacy. The record shall be made readily retrievable and maintained for a period of three years.

(3) The central fill pharmacy and originating pharmacy shall have access to common electronic files as part of a real time, online database or have appropriate technology to allow secure access to sufficient information necessary or required to dispense or process the prescription.

(4) The originating pharmacy shall comply with the minimum required information for a patient profile pursuant to rule 4729:5-5-07 of the Administration Code prior to sending a prescription to the central fill pharmacy.

(5) The originating pharmacy shall remain responsible for compliance with the dangerous drug dispensing requirements of this chapter and the compounding requirements of Chapter 4729:7-2 of the Administrative Code that are not assumed in writing by the central fill pharmacy.

(6) The prescription label attached to the container shall contain the name and address of the originating pharmacy. The date on which the prescription was dispensed shall be the date on which the central fill pharmacy filled the prescription.

(a) If the originating pharmacy and the central fill pharmacy are not under common ownership, either of the following shall apply:

(i) The name of the central fill pharmacy shall be included on the prescription label or an auxiliary label; or

(ii) A statement is included on the prescription information accompanying the dangerous drug that indicates a central fill pharmacy was used to fill the prescription and includes the name of the central fill pharmacy.

(7) The originating pharmacy shall provide, upon the request of a patient or caregiver, the name and address of the central fill pharmacy and a contact phone number where the patient or caregiver can receive further assistance regarding prescriptions filled by a central fill pharmacy.

(8) The originating pharmacy shall maintain the original of all prescription orders received for purposes of filing and recordkeeping as required by state and federal law, rules, and regulations.

(9) The central fill pharmacy shall maintain all original fill and refill requests received from the originating pharmacy and shall treat them as original and refill prescription orders for purposes of filing and recordkeeping as required by state and federal law, rules, and regulations.

(10) The central fill pharmacy and originating pharmacy shall each maintain records to capture the positive identification of the licensed or registered individuals responsible for performing respective activities in accordance with paragraph (A) of rule 4729:5-5-04 of the Administrative Code.

(11) The central fill pharmacy and originating pharmacy shall adopt a written quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, resolve identified problems and ensure compliance with this rule. The quality assurance plan shall be reviewed and updated annually.

(C) Dangerous drugs may be returned by the originating pharmacy to the central fill pharmacy that originally filled the prescription for the express purpose of being returned to the central fill pharmacy's stock shelves in accordance with the following:

(1) The central fill pharmacy complies with the requirements of rule 4729:5-3-16 of the Administrative Code; and

(2) The originating and central fill pharmacy are under common ownership and control.

(D) An originating pharmacy may return dangerous drugs received by a central fill pharmacy to stock shelves in accordance with rule 4729:5-3-16 of the Administrative Code.

(E) A central fill pharmacy may dispense a prescription directly to a patient pursuant to the following requirements:

(1) A prospective drug utilization review is conducted pursuant to a written contract or agreement in accordance with rule 4729:5-5-08 of the Administrative Code;

(2) Patient counseling is provided pursuant to a written contract or agreement in accordance with rule 4729:5-5-09 of the Administrative Code;

(3) The dispensing is conducted in accordance with all other applicable state and federal laws, regulations and rules, including those specified in 68 CFR 37405 (7/24/2003).

(F) All written documentation required by this rule shall be maintained for three years from the date of execution or review and shall be made readily retrievable.

(G) Drugs that are repackaged or relabeled by a central fill pharmacy shall comply with the requirements of rule 4729:5-5-17 of the Administrative Code.

Last updated February 1, 2022 at 9:15 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-20 Remote outpatient prescription processing.

(A) As used in this rule:

(1) "Remote prescription processing" means the processing of a prescription for an outpatient pharmacy licensed as a terminal distributor of dangerous drugs by a remote pharmacist. Remote prescription processing does not include the dispensing of a drug, but may include receiving, interpreting, evaluating, clarifying and approval of prescriptions. Additionally, remote prescription order processing may include order entry, other data entry, performing prospective drug utilization review, interpreting clinical data, performing therapeutic interventions, and providing drug information services. The requirements of this rule shall be limited to the processing of outpatient prescriptions dispensed in or into this state.

(2) "Remote pharmacy" means either:

(a) A pharmacy licensed as a terminal distributor of dangerous drugs that dispenses dangerous drugs; or

(b) A pharmacy licensed as a limited category II terminal distributor of dangerous drugs that does not stock, own, or dispense any dangerous drugs and whose sole business consists of entry, review, and/or verification of prescriber orders and consulting services under contract for outpatient pharmacies in this state.

(3) "Remote pharmacist" means any of the following:

(a) If performing remote prescription processing in this state: an Ohio licensed pharmacist, either employed or a contract employee of an outpatient pharmacy or remote pharmacy, who either processes prescriptions from a remote site, which may include the pharmacist's residence or other location where the pharmacist and the outpatient or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or outpatient pharmacy; or

(b) If performing remote prescription processing outside of this state: a pharmacist licensed or registered in the state where the remote prescription processing is occurring, either employed or a contract employee of an outpatient pharmacy or remote pharmacy who holds a nonresident pharmacy license in accordance with Chapter 4729:5-8 of the Administrative Code, who either processes prescriptions from a remote site, which may include the pharmacist's residence or other location where the pharmacist and the outpatient or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or outpatient pharmacy.

A pharmacist shall only be permitted to conduct remote prescription processing within the United States, to include the District of Columbia, the Commonwealth of Puerto Rico or a territory or insular possession subject to the jurisdiction of the United States.

(B) An outpatient pharmacy may outsource prescription processing to a remote pharmacy provided the pharmacies are under common ownership or control or the outpatient pharmacy has entered into a written contract or agreement with a pharmacy that outlines the services to be provided and the responsibilities and accountabilities of each party to the contract or agreement in compliance with federal and state statutes and regulations.

(C) The outpatient pharmacy and remote pharmacy must maintain a copy of the contract or agreement in a readily retrievable manner for inspection and review by an agent, inspector, or employee of the board.

(D) An outpatient pharmacy utilizing remote prescription processing shall ensure that all remote pharmacists providing such services have been trained on the outpatient pharmacy's policies and procedures relating to prescription processing. The training of each pharmacist shall be documented.

(1) Such training shall include, but is not limited to, policies on drug and food allergy documentation, abbreviations, substitution, and prospective drug utilization review requirements in accordance with rule 4729:5-5-08 of the Administrative Code. The outpatient pharmacy and the remote pharmacy shall jointly develop a procedure to communicate changes in policies and procedures related to prescription processing.

(2) A terminal distributor of dangerous drugs may utilize one training program for all outpatient pharmacies under the terminal distributor's common ownership and control.

(E) An outpatient pharmacy utilizing remote pharmacists shall maintain or have access to a record of the name and address of each pharmacist, evidence of current pharmacist licensure in the state where the pharmacist is performing remote order processing, and the address of each location where the pharmacist will be providing remote prescription processing services.

(F) The outpatient pharmacy shall ensure that any remote pharmacist shall have secure electronic access to the outpatient pharmacy's patient information system and to other electronic systems that the on-site pharmacist has access to when the pharmacy is open.

(G) The remote pharmacist must be able to contact the prescriber issuing a prescription to discuss any concerns identified during the pharmacist's review of patient information and the order. A procedure must be in place to communicate any problems identified with the prescriber and the outpatient pharmacy.

(H) Each remote entry record must comply with all recordkeeping requirements for outpatient pharmacies, including capturing the positive identification of the remote pharmacist involved in the review and verification of the prescription.

(I) An outpatient pharmacy utilizing remote prescription processing is responsible for maintaining records of all prescriptions entered into their information system, including orders entered by a remote pharmacist. The system shall have the ability to audit the activities of the remote pharmacists.

(J) An outpatient pharmacy utilizing remote prescription processing services shall develop and implement a policy and procedure manual. A remote pharmacy shall maintain a copy of those portions of the policy and procedure manual that relate to the remote pharmacy's operations. Each manual shall include all the following:

(1) Outline the responsibilities of the outpatient pharmacy and the remote pharmacy;

(2) Include a list of the names, addresses, telephone numbers, and all license numbers of the pharmacies/pharmacists involved in remote prescription processing; and

(3) Include policies and procedures for:

(a) Protecting the confidentiality and integrity of patient information;

(b) Ensuring that no patient information is duplicated, downloaded, or removed from the outpatient pharmacy's patient information system;

(d) Complying with federal and state statutes and regulations;

(e) Reviewing written policies and procedures at least every three years, or upon the implementation of a significant change of written policies and procedures, and documentation of the review; and

(f) Annually reviewing the competencies of pharmacists providing remote prescription processing services.

Last updated November 30, 2021 at 8:28 AM

History

Effective: November 30, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-22 Return to stock in an outpatient pharmacy.

(A) As used in this rule:

(1) "Pharmacy delivery agent" means an employee of the pharmacy, United States postal service, or common or contract carrier who delivers dangerous drugs that have been dispensed.

(2) "Psychiatric outpatient facility" means a facility where psychiatric evaluation and treatment is provided on an outpatient basis.

(B) An outpatient pharmacy may return dangerous drugs to stock shelves that have been dispensed, but have never left the pharmacy (i.e. never picked up by a patient or caregiver) or the control of a pharmacy delivery agent (i.e. never delivered to a patient or caregiver), if the pharmacy complies with all of the following:

(1) The pharmacy has the capability to place the expiration date, as required by this rule, on the prescription label.

(2) The expiration date on the label shall not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier. If multiple manufacturer containers are used, the expiration date shall not exceed the expiration date on the manufacturer's container that will expire first or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier. If the prescription container is the manufacturer's original sealed packaging, the expiration date is the expiration date listed on the packaging.

(3) The dangerous drug products returned to stock shelves shall be maintained in the container in which they were filled and shall maintain their original prescription label containing the original expiration date assigned. The label on the container shall not be removed, altered, or replaced with another label or have any other label added, except as follows:

(a) Adding to or modifying the existing label, if the drug name, dose, and original expiration date are maintained.

(b) Adding a new label over the existing label on the container. In this instance, the drug shall be verified by a pharmacist or an electronic verification system following the application of the new label. The new label shall include the expiration date assigned on the original label.

(c) A prescription label may be removed if the prescription container is the manufacturer's original sealed packaging and the removal of the label does not remove or otherwise cause to make unreadable the expiration date and lot number on the manufacturer's packaging.

(4) The contents of a prescription vial or container shall not be returned to the manufacturer's stock bottle.

(5) When dispensing a dangerous drug that was previously returned to stock to another patient, a new container shall be used or, in the case of unit dose or unit of use products, all previous patient information shall be removed.

(6) Drugs returned to stock shelves shall be stored in accordance with rule 4729:5-5-02 of the Administrative Code. The pharmacy shall develop and implement a policy to ensure that drugs are maintained by pharmacy delivery agents within temperatures as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(7) In the case of recalls, any drugs returned to stock shelves containing the drug affected by the recall shall be removed from the shelves immediately, unless the lot number can be determined.

(8) A dangerous drug that leaves the prescription department of the pharmacy in the custody of a pharmacy delivery agent may only be returned to stock shelves if the drug meets either of the following prior to initially leaving the prescription department:

(a) Each dangerous drug prescription is dispensed in a tamper evident container or package prior to leaving the pharmacy; or

(b) The dangerous drug prescription is dispensed in the manufacturer's original tamper evident packaging.

(9) A dangerous drug that is dispensed and shows any signs of tampering or adulteration shall not be returned to stock shelves.

(C) A dangerous drug that exceeds its assigned expiration date, as described in paragraph (B) of this rule, shall be removed from the area for the storage of drugs used for dispensing and administration in accordance with rule 4729:5-3-06 of the Administrative Code.

(D) Non-controlled drugs dispensed by a government entity and delivered for outpatients to a psychiatric outpatient facility or to any service provider licensed as a terminal distributor of dangerous drugs may be returned to stock if all the following apply:

(1) The drugs are packaged in unopened, single-dose or tamper-evident containers; and

(2) The drugs have not been in the possession of the ultimate user.

(E) This rule does not apply to drugs dispensed for inpatients pursuant to agency 4729 of the Administrative Code. Drugs dispensed for inpatients may be returned to stock in accordance with the applicable provisions of agency 4729 of the Administrative Code.

(F) A pharmacy may transfer dangerous drugs that are returned to stock shelves that meet the requirements of this rule to another pharmacy if the transfer is conducted in accordance with paragraph (E) of rule 4729:5-3-09 of the Administrative Code.

Last updated September 14, 2026 at 2:11 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-23 Security, control and storage of dangerous drugs in an outpatient pharmacy.

(A) The following applies to an outpatient pharmacy licensed as a terminal distributor of dangerous drugs:

(1) Except as provided in paragraph (A)(6) of this rule, a pharmacist shall provide supervision of the dangerous drugs, hypodermics, D.E.A. controlled substance order forms, all records relating to the distribution of dangerous drugs, except where the board has granted permission for such records to be stored at a secure off-site location in accordance with this chapter of the Administrative Code, at all times in order to deter and detect theft or diversion.

(2) The pharmacy shall be separated from the merchandising or public areas.

(3) The pharmacist or pharmacists on duty:

(a) Shall be physically present at the licensed location and responsible for the security of the pharmacy and supervision of pharmacy personnel.

(b) If the pharmacy is located within a store or business, shall ensure that all dangerous drugs, controlled substances, and hypodermics that are delivered onto the premises of the store or business are immediately placed and secured in the pharmacy under the physical control of the pharmacist or pharmacists on duty or secured in a designated area in accordance with paragraph (A)(6)(i) of this rule.

(4) No person, other than a licensed pharmacist, may enter the pharmacy unless the person is on business directly concerning the operation, maintenance or repair of the pharmacy and a pharmacist employed by the pharmacy is physically present at the same time.

(5) All schedule II controlled substance dangerous drugs shall be stored in a securely locked, substantially constructed cabinet or safe and shall not be dispersed through the stock of dangerous drugs. The cabinet or safe shall remain locked and secured when not in use. Schedule III through V controlled substance dangerous drugs may be stored with Schedule II controlled substance dangerous drugs.

(6) Whenever a pharmacist cannot meet the supervision requirements in paragraph (A)(3)(a) of this rule, security of the pharmacy must be provided in accordance with the following:

(a) The pharmacy must be secured by either:

(i) A physical barrier (i.e. barricade) with suitable locks approved by the board. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board of any installation or modification to a physical barrier prior to implementation.

(ii) An alarm system approved by the board that is monitored by a central station for control and can detect unauthorized access to the pharmacy. The alarm system shall be tested on a biannual basis. The pharmacy or the entity that manages security for the pharmacy shall maintain testing records for three years from the date of testing and shall make such records readily retrievable. The pharmacy shall be responsible for obtaining testing records if such records are maintained by a third-party. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board of any installation or modification to an alarm system prior to implementation. This notification requirement does not apply if a pharmacy also utilizes an approved physical barrier in accordance with paragraph (A)(6)(a)(i) of this rule.

(b) Except as provided in paragraph (A)(6)(i) of this rule, the pharmacy must contain all dangerous drugs, hypodermics, and D.E.A. controlled substance order forms and every other item or product that requires the supervision or sale by a pharmacist.

(i) Keys to the pharmacy that are not in the possession of a licensed pharmacist that are maintained on-site shall be secured to prevent unauthorized access.

(ii) All combinations or access codes, including alarm codes, shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(d) All records relating to the distribution of dangerous drugs must be maintained in the pharmacy, except as follows:

(i) The board has granted permission for such records to be stored at a secure off-site location in accordance with this chapter of the Administrative Code; or

(ii) Any designated area outside the pharmacy used to store records that complies with paragraph (A)(6)(i) of this rule.

(e) No item, product, record, or equipment that must be accessible to anyone other than a pharmacist may be stored in the pharmacy.

(f) Only a pharmacist may have access to the pharmacy or stock of dangerous drugs or assume responsibility for the security of dangerous drugs, hypodermics, and any other item or product that requires the supervision or sale by a pharmacist.

(g) No prescription, dangerous drug, hypodermic, nor any other item or product that requires the supervision or sale by a pharmacist may be sold, given away, or disposed of at any time the pharmacy is closed.

(h) New or refill prescription orders may be deposited into a secured area within the building where the pharmacy is located when a pharmacist is not present. Only a pharmacist may have access to this secured area.

(i) Any designated area outside the pharmacy at the location licensed as a terminal distributor of dangerous drugs intending to be used for the storage of dangerous drugs, D.E.A. controlled substance order forms, hypodermics, and records relating to the distribution of dangerous drugs, except where the board has granted a permission for such records to be stored at a secure off-site location pursuant to this chapter of the Administrative Code, and every other item or product that requires the supervision or sale by a pharmacist shall meet the following requirements:

(i) The designated area shall be secured by an approved physical barrier with suitable locks to detect unauthorized entry. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board of any installation or modification to a physical barrier prior to implementation.

(ii) No item, product, record, or equipment that must be accessible to anyone other than a pharmacist may be stored in the designated area, unless authorized by the board of pharmacy.

(iii) Authorized personnel may have access if there is supervision by a pharmacist.

(iv) No controlled substances may be stored outside of the pharmacy, except as authorized under division 4729:10 of the Administrative Code.

(j) If an outpatient pharmacy provides services by means of a drive-through facility, the drive-through facility shall be constructed and maintained in a manner, and with materials, that secures the premises of the pharmacy from unauthorized access.

(B) Refrigerators and freezers used for the storage of dangerous drugs shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store dangerous drugs.

(C) Upon the initial puncture of a multiple-dose vial containing a drug, the vial shall be labeled with a beyond-use date or date opened. The beyond-use date for an opened or entered (e.g., needle punctured) multiple-dose container with antimicrobial preservatives is twenty-eight days, unless otherwise specified by the manufacturer. A multiple-dose vial that exceeds its beyond-use date shall be deemed adulterated.

Last updated May 19, 2026 at 4:58 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-24 Drug inventory records and other record keeping provisions.

(A) Records of receipt shall contain the name, strength, dosage form, and quantity of the dangerous drugs received, the name and address of the seller, the name and address of the recipient, and the date of receipt.

(B) Temperature logs maintained in accordance with paragraph (B) of rule 4729:5-5-23 of the Administrative Code shall include either:

(1) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(2) For automated systems that provide temperature monitoring, either of the following:

(a) A report that provides, at a minimum, the date and time of observation and the temperature recorded; or

(b) A report that provides temperature excursions, if any, and the date, time, temperature recorded, and length of the noted excursion.

(C) Records of dangerous drugs disposed from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and the positive identification of the licensed or registered health care professional that performed the disposal.

(D) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory is performed on-site, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal, one of whom shall be a pharmacist.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal.

(E) Records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code shall contain the name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(F) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) Complies with the requirements of this rule;

(2) All paper records maintained electronically shall be scanned in full color via technology designed to capture all information in the paper record in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features to prevent unauthorized access to the records; and

(4) Contains daily back-up functionality to protect against record loss.

(G) All records maintained in accordance with this chapter shall be readily retrievable and uniformly maintained for a period of three years.

(H)

(1) Except as provided for in paragraph (H)(2) of this rule, all records maintained in accordance with this chapter shall be maintained on-site.

(2) An outpatient pharmacy located in this state intending to maintain records at a location other than the location licensed by the state board of pharmacy shall send a request in a manner determined by the board. The board will provide written or electronic notification to the outpatient pharmacy documenting the approval or denial of the request. A copy of the board's approval shall be maintained at the licensed location. Any such alternate location used to store records shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(I) All records required in accordance with this chapter shall comply with the following:

(1) Be maintained under appropriate supervision and control to restrict unauthorized access, including security features to prevent unauthorized access to computerized records; and

(2) All computerized records shall contain daily back-up functionality to protect against record loss.

(J) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

Last updated May 19, 2026 at 5:04 PM

History

Effective: August 19, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-25 Remote prescription entry - technician.

(A) As used in this rule:

(1) "Direct supervision" and "personal supervision" have the same meaning as in rule 4729:3-1-01 of the Administrative Code.

(2) "Remote prescription entry" means the entry of prescriptions for an outpatient pharmacy licensed as a terminal distributor of dangerous drugs by a remote technician under the direct supervision or remote supervision of a pharmacist. Remote prescription entry does not include dispensing, interpreting, evaluating, or approval of prescriptions or any other activities not permitted by state or federal laws, rules, and regulations. Remote prescription entry may include clarifying prescriptions and other data entry, including the processing of insurance coverage. The requirements of this rule shall be limited to the entry of prescriptions dispensed in or into this state.

(3) "Remote pharmacy" means either:

(a) A pharmacy licensed as a terminal distributor of dangerous drugs that dispenses dangerous drugs; or

(b) A pharmacy licensed as a limited category II terminal distributor of dangerous drugs which does not stock, own, or dispense any dangerous drugs, and whose sole business consists of entry, review, and/or verification of prescriber orders and consulting services under contract for outpatient pharmacies in this state.

(4) "Remote supervision" means that a pharmacist directs and controls the actions of remote technicians through the use of technology that ensures a supervising pharmacist can meet the requirements listed in this paragraph. A pharmacist providing remote supervision shall:

(a) Be readily available to answer questions of a remote technician; and

(b) Be fully responsible for the practice and accuracy of the remote technician.

(5) "Remote technician" means any of the following:

(a) If performing remote prescription entry in this state: an Ohio registered certified pharmacy technician, registered pharmacy technician, or pharmacy technician trainee, either employed or a contract employee of an outpatient pharmacy or remote pharmacy, who either conducts prescription entry from a remote site, which may include the technician's residence or other location where the technician and the outpatient or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or outpatient pharmacy; or

(b) If performing remote prescription entry outside of this state: a pharmacy technician who meets the following criteria:

(i) The pharmacy technician is licensed or registered in the state where the remote prescription entry is occurring, or if working in a state that has not yet implemented a technician registration process, has received training and is working as a pharmacy technician in accordance with of the laws and regulations of their state of practice; and

(ii) The pharmacy technician is either employed or a contract employee of an outpatient pharmacy or remote pharmacy who holds a nonresident pharmacy license in accordance with Chapter 4729:5-8 of the Administrative Code, who either conducts prescription entry from a remote site, which may include the technician's residence or other location where the technician and the outpatient or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or outpatient pharmacy.

(c) A nonresident pharmacy shall be responsible for ensuring all actions performed by an unregistered technician comply with the applicable requirements for conducting remote prescription entry.

(d) A remote technician shall only be permitted to conduct remote prescription entry within the United States, to include the District of Columbia, the Commonwealth of Puerto Rico or a territory or insular possession subject to the jurisdiction of the United States.

(B) An outpatient pharmacy may outsource prescription entry to a remote pharmacy provided the pharmacies are under common ownership or control or the outpatient pharmacy has entered into a written contract or agreement with a pharmacy that outlines the services to be provided and the responsibilities and accountabilities of each party to the contract or agreement in compliance with federal and state statutes and regulations.

(D) An outpatient pharmacy utilizing remote prescription entry shall ensure that all remote technicians providing such services have been trained on the outpatient pharmacy's policies and procedures relating to prescription entry.

(1) The training of each remote technician shall be documented. The outpatient pharmacy and the remote pharmacy shall jointly develop a procedure to communicate changes in policies and procedures related to prescription entry.

(2) A terminal distributor of dangerous drugs may utilize one training program for all outpatient pharmacies under the terminal distributor's common ownership and control.

(E) An outpatient pharmacy utilizing remote technicians shall maintain or have access to a record of the name and address of each technician, evidence of current licensure or registration, and the address of each location where the technician will be providing remote prescription entry services.

(F) The outpatient pharmacy shall ensure that any remote technician shall have secure electronic access to the outpatient pharmacy's patient information system and to other electronic systems that an on-site technician has access to when the pharmacy is open.

(G) Each remote entry record must comply with all recordkeeping requirements for outpatient pharmacies, including capturing the positive identification of the remote technician involved in the entry of the prescription.

(H) An outpatient pharmacy utilizing remote prescription entry is responsible for maintaining records of all prescriptions entered into their information system, including prescriptions entered by a remote technician.

(I) An outpatient pharmacy utilizing remote prescription entry services shall develop and implement a policy and procedure manual. A remote pharmacy shall maintain a copy of those portions of the policy and procedure manual that relate to the remote pharmacy's operations. Each manual shall include all the following:

(1) An overview of the responsibilities of the outpatient pharmacy and the remote pharmacy;

(2) A list of the names, addresses, telephone numbers, and all license numbers of the pharmacies and remote technicians involved in remote prescription entry; and

(3) Policies and procedures for:

(a) Protecting the confidentiality and integrity of patient information;

(b) Ensuring that no patient information is duplicated, downloaded, or removed from the outpatient pharmacy's patient information system;

(d) Complying with federal and state statutes and regulations; and

(e) Reviewing written policies and procedures at least every three years or upon the implementation of a significant change of written policies and procedures and documentation of the review.

(J) A pharmacy intern that is licensed in this or any other state may engage in remote prescription entry pursuant to the requirements of this rule.

Last updated November 30, 2021 at 8:28 AM

History

Effective: November 30, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-26 Outpatient pharmacy delivery services.

(A) As used in this rule:

(1) "Business day" means any day, excluding holidays, where the pharmacy is open for business.

(2) "Common carrier" means a person holding itself out to the general public to provide transportation for compensation.

(3) "Contract carrier" means a person providing transportation for compensation under continuing agreements with one person or a limited number of persons.

(4) "Pharmacy delivery agent" means the United States postal service or common carrier, contract carrier, or employee of the terminal distributor of dangerous drugs who delivers dangerous drugs that have been dispensed to a patient or agent of the patient.

(5) "Temperature sensitive drug" means any drug that is required to be stored at temperatures outside of controlled room temperature (fifty-nine degrees Fahrenheit to eighty-six degrees Fahrenheit).

(B) An outpatient pharmacy licensed as a terminal distributor of dangerous drugs providing delivery services of dispensed drugs and devices in this state shall comply with the following:

(1) Contact the patient or patient's caregiver for consent prior to any billing or delivery of a drug or device, except if the patient has provided general consent for delivery services. Consent may be provided in writing, electronically, or verbally. In lieu of contacting the patient or patient's caregiver to obtain consent, the pharmacy shall provide a refund if the patient or patient's caregiver notifies the pharmacy that a dispensed drug or device was unneeded or unwanted.

(2) In accordance with the patient's communication preferences, make available to the patient or patients caregiver the date shipped, method of delivery (e.g., mail, courier, drone, etc.), and expected arrival. This information can be provided by electronic, telephonic, or any other manner that allows the patient to access the information required pursuant to this paragraph.

(3) Take all appropriate measures to ensure that temperature sensitive drugs will be maintained within the temperature ranges recommended by the manufacturer until the delivery has been completed.

(4) If the patient's prescription is a temperature sensitive drug, provide notification to the patient of the timeliness in addressing proper storage of the medication.

(5) Arrange for any controlled substances to require proof of delivery, which may include the signature of the receiving party.

(6) Assist patients with arranging access to medication from a local pharmacy if unable to deliver medications in the expected timeframe.

(7) Provide a method by which the patient or patient's caregiver can notify the pharmacy as to any irregularity in the delivery of the drug or device, including all of the following:

(a) Timeliness of delivery.

(b) Condition of the drug or device upon delivery.

(8) Ensure there is a process to inform the patient or patient's caregiver within two business days of being notified of the delay if the scheduled delivery of the patient's prescription will be interrupted or late.

(C) Upon notification of the dispensing pharmacy by the patient or patient's caregiver, any drug or device which is compromised or lost in transit shall be replaced at no additional cost to the patient. If the timeliness of the replacement will lead to an interruption in therapy, the outpatient pharmacy shall take all available steps to mitigate patient harm.

(D) Any drug or device that has been delivered to a patient or is no longer in the possession of a pharmacy delivery agent shall not be returned to stock in accordance with rule 4729:5-5-22 of the Administrative Code.

(E) An outpatient pharmacy shall maintain the following records for all drugs and devices delivered in accordance with this rule:

(1) Patient name;

(2) Patient address;

(3) Prescription number of drug or device being delivered;

(4) Name (brand name or generic) and dosage of each drug or device being delivered;

(5) Name of the pharmacy delivery agent who performed, or attempted to perform, the delivery as follows:

(a) For the United State postal service (USPS) or a common carrier, the record shall indicate either the USPS or the name of the common carrier.

(b) For a contract carrier, the record shall indicate the name of the contract carrier and the individual conducting the delivery on behalf of the contract carrier.

(c) For an employee of the terminal distributor of dangerous drugs, the record shall include the full name of the employee.

(F) All records maintained in accordance with this rule shall be readily retrievable and uniformly maintained for a period of three years.

(G) Except for deliveries performed by the United States postal service or common carrier, an outpatient pharmacy that utilizes a third-party to deliver drugs and devices shall enter into a contract with the third-party to ensure the following:

(1) The required records in paragraph (E) of this rule are provided to the contracting pharmacy; and

(2) The third-party entity agrees to cooperate with all investigations regarding the theft or significant loss of drugs and devices and produce required records listed in paragraph (E) of this rule within three business days of a request by an agent, officer, or employee of the board.

(H) Theft or significant loss of any dangerous drugs shall be reported to the board in accordance with rule 4729:5-3-02 of the Administrative Code.

Last updated June 30, 2025 at 8:07 AM

History

Effective: June 30, 2025
Promulgated Under: 119.03

Chapter 4729:5-6 Nuclear Pharmacies

Ohio Adm.Code 4729:5-6-01 Definitions - nuclear pharmacies and radiopharmaceuticals.

As used in Chapter 4729:5-6 of the Administrative Code:

(A) "Radiopharmaceutical," "radiopharmaceutical preparation," or "radioactive drug" means a finished dosage form of a dangerous drug that contains a radioactive substance in association with one or more other ingredients and that is intended to diagnose, stage a disease, monitor treatment, or provide therapy. A radiopharmaceutical includes any nonradioactive reagent kit or radionuclide generator that is intended to be used in the preparation of any such substance. The terms "radiopharmaceutical" and "radioactive drug" are commonly used interchangeably.

(B) "Authorized nuclear pharmacist" means a licensed pharmacist that meets the requirements in rule 3701:1-58-20 of the Administrative Code.

(D) "Compounding" has the same meaning as in USP <825>.

(E) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(F) "Dispense" means the final association of a drug with a particular patient pursuant to a prescription, drug order, or other lawful order of a prescriber and the professional judgment of and the responsibility for interpreting, preparing, compounding, labeling, and packaging a specific drug.

(G) "Final check" means the final verification check for accuracy and conformity to the formula of the compounded preparation or product being prepared, correct ingredients and calculations, accurate and precise measurements, appropriate conditions and procedures, and appearance of the final product.

(H) "Kit" means a commercially manufactured package containing all ingredients required to prepare a radiopharmaceutical with the exception of the radionuclide.

(I) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as in rule 4729:5-1-02 of the Administrative Code but shall be limited to a prescriber practicing within the prescriber's applicable scope of practice.

(J) "Non-sterile compounded drug" means a dangerous drug preparation intended to be nonsterile.

(K) "Nuclear pharmacy" is a pharmacy licensed as a terminal distributor of dangerous drugs where prescriptions for radiopharmaceuticals are prepared, compounded, dispensed, or repackaged. A nuclear pharmacy shall also be licensed by the United States nuclear regulatory commission or the appropriate state nuclear regulatory agency.

(L) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to provide personal review and approval of all professional activities.

(M)

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(g) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who prescribed, administered, or dispensed the dangerous drug. The printout must be maintained for three years and made readily retrievable; or

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system.

(N) "Preparing" or "preparation" means the act of combining a conventionally manufactured kit with a conventionally manufactured radionuclide following manufacturer's recommended instructions. Mixing, reconstituting, combining, diluting, or repackaging of a radiopharmaceutical, or other such acts, performed in accordance with directions contained in the FDA-approved labeling.

(O) "Preparation with minor deviation" means the act of preparing conventionally manufactured radionuclide with volume, and/or radioactivity, and/or step-by-step deviations from the manufactures recommended labeling while ensuring that the final preparation maintains appropriate radiochemical and radionuclidic purity for the entirety of the beyond-use date.

(P) "Product" means a drug in a commercially manufactured pharmaceutical dosage form that has been evaluated for safety and efficacy by the United States food and drug administration. Products are accompanied by full prescribing information, which is commonly known as the United States food and drug administration-approved manufacturer's labeling or product package insert.

(Q) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(R) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

(1) Except as provided in paragraph (R)(2) of this rule, a nuclear pharmacy shall have an authorized nuclear pharmacist as its responsible person. Responsible person shall also mean the "designated person" as used in USP 825.

(2) An institutional facility licensed as a terminal distributor of dangerous drugs with an on-site nuclear pharmacy that is engaged in the preparation, preparation with minor deviation, compounding, dispensing, or repackaging of radiopharmaceuticals shall comply with the following:

(a) Submit notification to the board, in a manner determined by the board, that the facility is engaged in the preparation, preparation with minor deviation, compounding, dispensing, or repackaging of radiopharmaceuticals.

(i) For new facilities, the institutional facility shall notify the board within ten days of the date the facility engages in the preparation, preparation with minor deviation, compounding, dispensing, or repackaging of radiopharmaceuticals.

(ii) For existing facilities, the institutional facility shall notify the board within ten days of the effective date of this rule.

(b) A nuclear pharmacy that ceases to engage in the preparation, preparation with minor deviation, compounding, dispensing, or repackaging of radiopharmaceuticals shall submit notification to the board, in a manner determined by the board, within ten days of cessation.

(c) The facility shall have a designated person who is an authorized nuclear pharmacist employed by the facility that is responsible and accountable for the performance and operation of the radiopharmaceutical processing facility and for personnel who prepare, prepare with minor deviation, compound, dispense, personally furnish, and repackage radiopharmaceuticals.

(i) For new facilities, the institutional facility shall notify the board of the designated person within ten days of the date the nuclear pharmacy in a facility engages in the preparation, preparation with minor deviation, compounding, dispensing, personally furnishing, or repackaging of radiopharmaceuticals.

(ii) For existing facilities, the institutional facility shall notify the board of the designated person within ten days of the effective date of this rule.

(iii) If there is a change in the designated person, the board shall be notified within ten days of the effective date of the appointment of the new designated person.

(S) "Sterile" means a dosage form free of living microorganisms (aseptic).

(T) "Sterile compounded drug" means a dangerous drug preparation intended to be sterile.

(U) "United States Pharmacopeia Chapter <825>" or "USP <825>" means United States Pharmacopeia Chapter <825>, USP 42-NF 37 2S, or any official supplement thereto (12/1/2020).

Last updated February 2, 2022 at 10:10 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-6-02 Applicability.

(A) The provisions in this chapter apply to the preparation, preparation with minor deviation, compounding, dispensing, or repackaging of radiopharmaceuticals for humans and animals prepared by a pharmacy, including an institutional facility, licensed as a terminal distributor of dangerous drugs. These standards apply to all radiopharmaceuticals, including those with radionuclides that emit a single photon, a positron, or a therapeutic particle, and intravascular radioactive devices (e.g. radioactive microspheres).

(B) This chapter does not apply to the preparation, preparation with minor deviation, compounding, dispensing, personally furnishing, and repackaging of non-radioactive drugs, including those used as pharmacologic adjuncts for certain nuclear medicine procedures. These drugs shall be prepared in accordance with the applicable provisions of division 4729:7 of the Administrative Code.

(C) Except if specifically stated in this chapter, an outpatient pharmacy shall also comply with Chapter 4729:5-5 of the Administrative Code.

(D) Except if specifically stated in this chapter, an institutional pharmacy shall also comply with Chapter 4729:5-9 of the Administrative Code.

(E) Except if specifically stated in this chapter, a nonresident nuclear pharmacy shall comply with the requirements of rule 4729:5-8-05 of the Administrative Code.

(F) All terminal distributors of dangerous drugs engaged in the preparation, preparation with minor deviation, compounding, dispensing, or repackaging of radiopharmaceuticals for humans and animals shall comply with Chapter 3701:1-58 of the Administrative Code.

Last updated February 2, 2022 at 10:10 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-6-03 Preparation, compounding, labeling, dispensing, and repackaging of radiopharmaceuticals.

(A) A terminal distributor of dangerous drugs engaged in the preparation, compounding, dispensing, or repackaging of radiopharmaceuticals for humans and animals shall comply with USP <825>.

(B) All radiopharmaceuticals shall be dispensed pursuant to a patient-specific prescription issued by a licensed health professional authorized to prescribe drugs.

(1) A limited quantity may be prepared and distributed in anticipation of prescriptions based on routine, regularly observed prescribing patterns.

(2) In the event a patient's name is not available at the time of dispensing, a nuclear pharmacy shall have up to seventy-two hours to obtain the name of the patient. No later than seventy-two hours after dispensing the radiopharmaceutical, the patient's name must be associated with the prescription in the dispensing records maintained in accordance with rule 4729:5-6-04 of the Administrative Code.

(1) Radiopharmaceuticals shall be labeled in accordance with USP <825>.

(2) In addition to the requirements in paragraph (C)(1) of this rule, the outer shielding shall also be labeled with the following:

(a) The name and telephone number of the pharmacy;

(b) The prescription number; and

(c) The patient's name (first name and last name or first initial and last name), if available at the time of dispensing.

(3) In addition to the requirements in paragraph (C)(1) of this rule, the immediate container shall also be labeled with the following information:

(a) The prescription number; and

(b) The patient's name (first name and last name or first initial and last name), if available at the time of dispensing.

(D) A terminal distributor shall ensure that all employees comply with all applicable local, state, and federal requirements for the proper labeling, environmental controls, integrity, and safety of all products transported.

(E) A terminal distributor shall ensure that all employees comply with all applicable local, state, and federal requirements for the disposal of radioactive and/or biohazardous waste in a manner so as not to endanger the health and safety of the public.

(F) All personnel trained to work with radiopharmaceuticals shall do so under the personal supervision of an authorized nuclear pharmacist.

(G) A terminal distributor shall report any event as a medical event, except for an event that results from patient intervention, to the Ohio department of health in accordance with rule 3701:1-58-101 of the Administrative Code.

Last updated February 2, 2022 at 10:10 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-6-04 Record keeping.

(A) In addition to the applicable record keeping requirements of division 4729:5 of the Administrative Code, a terminal distributor shall maintain records in compliance with USP <825> for all activities involved in repackaging, preparing, preparing with minor deviations, compounding, or dispensing radiopharmaceuticals.

(B) In addition to the requirements set forth in paragraph (A) of this rule, there shall be positive identification of the authorized nuclear pharmacist conducting the final check of the radiopharmaceutical.

(C) All records maintained in accordance with this rule shall be readily retrievable and uniformly maintained for at least three years.

(1) Except as provided in paragraph (C)(2) of this rule, all records maintained in accordance with this chapter shall be kept on-site.

(2) A pharmacy located in this state intending to maintain records at a location other than the location licensed by the state board of pharmacy shall send a request in a manner determined by the board. The board will provide written or electronic notification to the outpatient pharmacy documenting the approval or denial of the request. A copy of the board's approval shall be maintained at the licensed location. Any such alternate location used to store records shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(D) All records maintained pursuant to this chapter may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) Complies with the requirements of this rule;

(3) Contains security features, such as unique user names and passwords, to prevent unauthorized access to the records; and

(4) Contains daily back-up functionality to protect against record loss.

(E) All records required in accordance with this chapter shall be maintained under appropriate supervision and control to restrict unauthorized access.

Last updated February 2, 2022 at 10:10 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Chapter 4729:5-7 Charitable Pharmacies

Ohio Adm.Code 4729:5-7-01 Definitions - Charitable pharmacies.

As used in Chapter 4729:5-7 of the Administrative Code:

(A) "Charitable pharmacy" means a pharmacy that meets all of the following requirements:

(1) Holds a terminal distributor of dangerous drug license issued under section 4729.54 of the Revised Code;

(2) Is exempt from federal taxation pursuant to 26 U.S.C. 501(a) and (c)(3) (5/28/2015); and

(3) Is not a hospital as defined in section 3727.01 of the Revised Code.

(B) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(C) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(D) "Sample drug" has the same meaning as in section 2925.01 of the Revised Code.

Last updated April 15, 2024 at 1:33 PM

History

Effective: July 1, 2019
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-7-02 Licensure, compliance, and support personnel.

(A) A pharmacy seeking authorization to be a charitable pharmacy shall maintain a terminal distributor of dangerous drug license. An application for licensure shall include the following:

(1) A completed terminal distributor application requesting licensure as a charitable pharmacy;

(2) Documentation to support the exemption from federal taxation pursuant to 26 U.S.C. 501(a) and (c)(3) (5/28/2015);

(3) The fee for the appropriate category of licensure; and

(4) Any other requirements set forth in division 4729:5 of the Administrative Code.

(B) A charitable pharmacy is considered to be a pharmacy pursuant to section 4729.01 of the Revised Code and shall comply with all federal and state laws, rules, and regulations that pertain to outpatient pharmacies and the practice of pharmacy, including Chapter 4729:5-5 of the Administrative Code.

(C) A charitable pharmacy may designate employees and volunteers as support personnel, as defined in rule 4729:3-1-01 of the Administrative Code, for the purposes of sorting donations of non-controlled substance dangerous drugs.

(1) Drug sorting shall be conducted under the personal supervision of a licensed pharmacist.

(2) Support personnel are not permitted to label, package, repackage, or dispense dangerous drugs.

(3) The charitable pharmacy shall have written policies and procedures for drug sorting by support personnel. Such policies and procedures shall require documentation of all activities related to drug sorting, including participation logs, support personal information (name, address, contact phone, etc.), and a daily activity log to be signed by the licensed pharmacist or pharmacists providing supervision. All documents and records must be readily retrievable and shall be maintained on-site for a period of three years.

Last updated July 1, 2024 at 5:29 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-7-03 Persons eligible to transfer sample drugs to a charitable pharmacy.

(A) An eligible sample drug shall only be transferred directly to a charitable pharmacy by any of the following:

(1) A manufacturer licensed in accordance with section 4729.52 of the Revised Code, including a representative of the manufacturer;

(2) A person licensed in accordance with section 4729.52 of the Revised Code acting on behalf of a manufacturer; or

(3) A prescriber practicing at a location that is licensed as a terminal distributor of dangerous drugs, unless exempt from licensure pursuant to section 4729.541 of the Revised Code.

(B) If a sample drug is transferred by a prescriber:

(1) A record must be created by the prescriber documenting the transfer. The record shall contain the:

(a) Name and address of the supplying prescriber;

(b) Name, strength, and quantity of the sample drug being transferred;

(d) Name and address of the charitable pharmacy receiving the sample drug.

(2) A copy of all required records documenting the transfer of a sample drug shall be kept by the prescriber and the charitable pharmacy for a minimum of three years and shall be stored in a readily retrievable manner.

(3) The prescriber shall not transfer a sample drug to a charitable pharmacy unless the sample drug was received directly from a manufacturer, a manufacturer's representative, or by a person licensed in accordance with section 4729.52 of the Revised Code acting on behalf of a manufacturer.

(4) The sample drug complies with the requirements of rule 4729:5-7-04 of the Administrative Code.

(5) The sample drug must not have any physical signs of tampering.

(6) The sample drug packaging must not have any physical signs of tampering.

(C) Nothing in this rule prohibits the donation of a sample drug to a charitable pharmacy operating as a drug repository in accordance with Chapter 4729:5-10 of the Administrative Code.

Last updated July 1, 2024 at 5:29 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-7-04 Eligibility requirements for sample drugs received by a charitable pharmacy.

An eligible sample drug received by a charitable pharmacy shall meet all the following requirements:

(A) The sample drug is in the original manufacturer's container and the container is clearly marked as a sample.

(B) Prior to being transferred, the sample drug has been stored under the proper conditions to prevent deterioration or adulteration.

(D) The sample drug is not expired.

(E) The sample drug is not a controlled substance.

Last updated April 15, 2024 at 1:34 PM

History

Effective: July 1, 2019
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-7-05 Dispensing a sample drug by a charitable pharmacy.

(A) A pharmacist in a charitable pharmacy must have a valid prescription prior to dispensing a sample drug to a patient.

(B) The pharmacy shall comply with all requirements for the dispensing of drugs pursuant to Chapter 4729:5-5 of the Administrative Code.

(D) The sample drug shall be dispensed to the patient free of charge.

(E) The sample drug may be dispensed:

(1) In the manufacturer's original container where the container is clearly marked as a sample; or

(2) By removing the sample drug from the original container only if the prescription label on the appropriate container, pursuant to all state and federal requirements, clearly states that the drug dispensed is a sample drug.

Last updated April 15, 2024 at 1:34 PM

History

Effective: July 1, 2019
Promulgated Under: 119.03

Chapter 4729:5-8 Non-resident Pharmacies

Ohio Adm.Code 4729:5-8-01 Definitions.

As used in Chapter 4729:5-8 of the Administrative Code:

(A) "Nonresident terminal distributor of dangerous drugs" or "nonresident terminal distributor" means any person located outside of Ohio that ships, mails, or delivers in any manner, dangerous drugs at retail into Ohio. A nonresident terminal distributor of dangerous drugs shall maintain a license in accordance with sections 4729.54 and 4729.55 of the Revised Code and shall comply with all requirements set forth in this chapter. A nonresident terminal distributor does not include a person shipping drugs into this state for destruction or disposal by an Ohio licensed reverse distributor.

(B) "Dangerous drug" has the same meaning as defined in section 4729.01 of the Revised Code.

(C) "Licensed health professional authorized to prescribe drugs" or "prescriber" means an individual who is authorized by law to prescribe drugs or dangerous drugs in the state where the individual is practicing.

(D) "Pharmacist," as used in division (B) of section 4729.55 of the Revised Code, means an individual who holds a current license to practice pharmacy in the state where the individual is practicing.

(E) "Pharmacy" has the same meaning as defined in section 4729.01 of the Revised Code.

(F) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and maintaining all drug records otherwise required.

Last updated December 2, 2024 at 1:40 PM

History

Effective: March 1, 2019
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-8-02 Licensure.

(A) A person seeking a license as a nonresident terminal distributor of dangerous drugs shall submit an application to the state board of pharmacy that includes all of the following:

(1) Information necessary to demonstrate the qualifications for licensure set forth in section 4729.55 of the Revised Code.

(2) If the applicant's facility maintains a current license in the state where it is located, all the following:

(a) Certification from the appropriate state licensing agency that the applicant maintains at all times a valid, unexpired license, permit, or registration authorizing the possession and sale of dangerous drugs in the state in which the facility is located and from where dangerous drugs are being sold at retail to residents in Ohio. The certification(s) shall include licenses, permits, or registrations required to cover the categories of dangerous drugs which the nonresident terminal distributor of dangerous drugs will be selling at retail to persons in the state of Ohio.

(b) A copy of the most recent inspection report, any warning notices, notice of deficiency reports, or any other related reports issued by a state licensing agency and drug law enforcement agencies of the state in which it is located or any federal agencies regulating and enforcing laws governing the legal distribution of drugs.

(3) Any other information as determined by the board.

(B) A nonresident terminal distributor shall have a responsible person that complies with the requirements of rule 4729:5-2-01 of the Administrative Code.

Last updated December 2, 2024 at 1:40 PM

History

Effective: February 15, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-8-03 Compliance.

A nonresident terminal distributor of dangerous drugs shall:

(A) Maintain the following records of all dangerous drugs dispensed or personally furnished to persons in this state:

(1) Name, strength, dosage form, the serial number of the prescription, and quantity of the dangerous drug dispensed or personally furnished;

(2) Full name and date of birth of the patient for whom the drug is intended; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals; and

(3) Residential address, including the physical street address and, if provided, the telephone number of the patient or owner.

(B) Maintain the following records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code for drugs sold or transferred into this state: name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(C) Maintain all records and documents required by this chapter for a period of three years in a readily retrievable manner.

(D) Label all drugs dispensed or personally furnished into this state with the following minimum information:

(1) The name or "doing business as" (DBA) name, or other legal or contractually affiliated name and address of the terminal distributor.

(2) The full name of the patient for whom the drug is prescribed; or, if the patient is an animal, the last name of the owner, name of animal (if applicable), and species of the animal or animals.

(3) The full name of the prescriber or the first initial of the prescriber's first name and the full last name of the prescriber.

(4) Directions for use of the drug.

(5) The date of dispensing.

(6) Any cautions which may be required by federal or state law.

(7) The serial number of the prescription.

(8) The proprietary name, if any, or the generic name and the name of the distributor or national drug code of the drug dispensed, and the strength, if more than one strength of the drug is marketed.

(9) The quantity of drug dispensed.

(10) If the licensee is an institutional central fill pharmacy as defined in rule 4729:5-9-02.13 of the Administrative Code, the prescription label attached to the container shall contain the name and address of the originating pharmacy and the name of the central fill pharmacy. If applicable, the date on which the medication order was dispensed shall be the date on which the central fill pharmacy filled the order.

(11) If the licensee is a central fill pharmacy as defined in rule 4729:5-5-19 of the Administrative Code, the prescription label attached to the container shall contain the name and address of the originating pharmacy. The date on which the prescription was dispensed shall be the date on which the central fill pharmacy filled the prescription.

(a) If the originating pharmacy and the central fill pharmacy are not under common ownership, either of the following shall apply:

(i) The name of the central fill pharmacy shall be included on the prescription label or an auxiliary label; or

(b) The originating pharmacy shall provide, upon the request of a patient or caregiver, the name and address of the central fill pharmacy and a contact phone number where the patient or caregiver can receive further assistance regarding prescriptions filled by a central fill pharmacy.

(E) Comply with all the statutory requirements of the state of Ohio set forth in Chapters 4729., 3719., 3715., and 2925. of the Revised Code for all drugs sold, dispensed or personally furnished into this state, unless the licensee can demonstrate that such compliance would cause the nonresident terminal distributor of dangerous drugs to violate either the statutory or regulatory requirements of the state in which it is located or federal statutory or regulatory requirements.

(F) Comply with the following regulatory requirements of the state of Ohio, unless the licensee can demonstrate that such compliance would cause the nonresident terminal distributor of dangerous drugs to violate either the statutory or regulatory requirements of the state in which it is located or federal statutory or regulatory requirements:

(1) The requirements set forth in this chapter;

(2) The requirements in Chapters 4729:5-1 and 4729:5-2 of the Administrative Code;

(3) Theft or significant loss reporting requirements in rule 4729:5-3-02 of the Administrative Code for all drugs sold, dispensed or personally furnished into this state;

(4) Inspection and corrective action requirements in rule 4729:5-3-03 of the Administrative Code;

(5) Licensure verification requirements in rule 4729:5-3-04 of the Administrative Code for all drugs sold, dispensed or personally furnished into this state;

(6) Patient confidentiality requirements in rule 4729:5-3-05 of the Administrative Code;

(7) Internet sales requirements in rule 4729:5-3-08 of the Administrative Code for all drugs sold, dispensed or personally furnished into this state;

(8) Occasional sale and drug transfer requirements in rule 4729:5-3-09 of the Administrative Code for all drugs sold, dispensed or personally furnished into this state;

(9) Remote medication order processing requirements in rule 4729:5-9-02.14 of the Administrative Code and remote outpatient prescription processing requirements in rule 4729:5-5-20 of the Administrative Code.

(10) The following central fill pharmacy requirements set forth in Chapters 4729:5-5 and 4729:5-9 of the Administrative Code:

(a) If the central fill pharmacy does not have the same owner as the originating pharmacy, the central fill pharmacy shall have a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract in compliance with federal and state law, rules and regulations. For central fill pharmacies dispensing outpatient prescriptions, the contract shall also expressly state who is responsible for performing the patient counseling requirements in accordance with paragraph (L) of this rule.

(b) The central fill pharmacy shall maintain a record of all originating pharmacies, including name, address, terminal distributor number, and, if applicable, drug enforcement administration registration number, for which it processes a request for the filling or refilling of a medication order or prescription received by the originating pharmacy.

(c) The central fill pharmacy and originating pharmacy shall have access to common electronic files as part of a real time, online database or have appropriate technology to allow secure access to sufficient information necessary or required to dispense or process the medication order or prescription.

(d) The central fill pharmacy and originating pharmacy shall adopt a written quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, resolve identified problems, and ensure compliance with this rule. The quality assurance plan shall be reviewed and updated annually.

(11) If engaged in the provision of medication therapy management, as defined in rule 4729:5-12-01 of the Administrative Code, for patients residing in this state the requirements set forth in Chapter 4729:5-12 of the Administrative Code.

(12) The delivery requirements in rule 4729:5-5-26 of the Administrative Code.

(G) Submit to the applicable disciplinary actions set forth in section 4729.57 of the Revised Code and rule 4729:5-4-01 of the Administrative Code.

(H) Operate in compliance with all applicable laws, regulations and standards set forth by the United States food and drug administration and the United States drug enforcement administration.

(I) Nonresident terminal distributors of dangerous drugs who are pharmacies shall dispense prescriptions into this state issued by either:

(1) An Ohio prescriber who is authorized pursuant rule 4729:5-1-02 of the Administrative Code; or

(2) A nonresident prescriber whose license is current and in good standing and who is authorized to issue prescriptions for dangerous drugs in the course of the prescriber's professional practice in a state other than Ohio.

(J) Supply, within three business days of a request, all information needed by the board of pharmacy to carry out its responsibilities as a licensing, regulatory, and drug law enforcement agency of the state of Ohio.

(K) Supply, within three business days of a request, all information needed by the board of pharmacy and any local, state, or federal agency to carry out its responsibilities in enforcing the federal and state laws governing the distribution of drugs in the state of Ohio.

(L) If the nonresident terminal distributor is a pharmacy, there must be an offer to counsel the patient issued with every prescription dispensed. The offer shall be made by telephone or in writing on a separate document and shall accompany the prescription. A written offer to counsel shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service must be available at no cost to the pharmacy's primary patient population. The pharmacy shall have sufficient telephone service to provide access to incoming callers.

(M) Nonresident terminal distributors shall permit properly identified and authorized state board of pharmacy agents and federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles. A nonresident terminal distributor of dangerous drugs shall be responsible for all costs incurred by board of pharmacy agents in conducting an inspection. Upon completion of the inspection, the nonresident terminal distributor of dangerous drugs shall have ninety days to reimburse all inspection costs incurred after being notified, electronically or in writing, by the board.

In lieu of an inspection by the board, a nonresident terminal distributor of dangerous drugs may submit any of the following:

(1) Inspection reports by a state licensing agency demonstrating compliance with the requirements of this rule.

(2) Inspection reports demonstrating compliance with the requirements of this rule by one of the following organizations:

(a) The national association of boards of pharmacy's verified pharmacy program (VIPP);

(b) An organization approved by the board.

(N) Comply with all drug database reporting requirements pursuant to Chapter 4729. of the Revised Code and division 4729:8 of the Administrative Code.

(O) Unless approved by the board's executive director, a nonresident terminal distributor of dangerous drugs that is not a pharmacy shall not be permitted to sell or personally furnish controlled substances to patients residing in this state.

Last updated June 30, 2025 at 8:08 AM

History

Effective: June 30, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-8-04 Drugs compounded by a nonresident pharmacy.

(A) Except as otherwise provided in this rule, the terms and references used in this rule have the same meaning as in rules 4729:7-1-01 and 4729:7-2-01 of the Administrative Code.

(B) For all non-sterile compounded drug preparations, a pharmacy licensed as a nonresident terminal distributor of dangerous drugs shall comply with United States pharmacopeia chapter <795>. The requirements of this rule do not apply to the preparation of non-hazardous, conventionally manufactured non-sterile products in accordance with the directions contained in the approved labeling provided by the product's manufacturer.

(C) For all sterile compounded drug preparations, a pharmacy licensed as a nonresident terminal distributor of dangerous drugs shall comply with United States pharmacopeia chapter <797>.

(D) For all antineoplastic compounded hazardous drug preparations listed in table one on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code, a pharmacy licensed as a nonresident terminal distributor of dangerous drugs shall comply with United States pharmacopeia chapter <800>.

(E) For all non-antineoplastic compounded hazardous drug preparations listed in table one on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code and for all compounded hazardous drug preparations listed in table two or three on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code, a pharmacy licensed as a nonresident terminal distributor of dangerous drugs shall comply with either:

(1) United States pharmacopeia chapter <800>; or

(2) All the following:

(a) Conduct a risk assessment for any hazardous drug preparations listed in paragraph (E) of this rule to determine if any additional containment strategies, work practices, and/or training is required to minimize occupational exposure. Risk assessments shall be made readily retrievable for review by an agent, inspector or employee of the state board of pharmacy. The risk assessment must be reviewed at least every twelve months and the review documented. If a risk assessment is not performed, the compounded drug preparations shall be prepared in accordance with paragraph (E)(1) of this rule. The risk assessment must, at a minimum, consider the following:

(i) Type of hazardous drug (e.g., non-antineoplastic or reproductive risk only);

(ii) Dosage form;

(iii) Risk of exposure;

(iv) Packaging; and

(v) Manipulation.

(b) Ensure that any employees of reproductive capability confirm in writing that they understand the potential risks of handling drugs listed in paragraph (E) of this rule.

(F) In addition to the labeling requirements set forth in this rule, the statement "Compounded Drug" or other similar statement shall be displayed prominently on the label of all compounded drug preparations sold in this state.

(G) A pharmacy licensed as a nonresident terminal distributor of dangerous drugs that engages in drug compounding shall comply with the following:

(1) Except as provided in paragraph (G)(2) of this rule, shall not sell, ship, mail, or deliver, in any manner, compounded drugs into Ohio unless it is pursuant to a patient specific prescription.

(2) May sell, ship, mail, or deliver, in any manner, non-patient specific compounded drugs for animal use pursuant to rule 4729:7-2-04 of the Administrative Code. Such compounding for office use shall comply with applicable federal laws and regulations.

(3) A pharmacy licensed as a non-resident pharmacy that is engaged in drug compounding shall have an Ohio licensed pharmacist as the responsible person on its license. This provision shall take effect on August 1, 2021.

(H) If a pharmacy is applying for an initial nonresident terminal distributor of dangerous drugs license, renewal, or the pharmacy's license has lapsed, the pharmacy must provide any of the following, in a manner determined by the board, as part of the initial or renewal application:

(1) The most recent inspection report that is less than two years old that demonstrates applicable compliance with this rule conducted by an agent of the regulatory or licensing agency in the pharmacy's resident jurisdiction or an agent of a regulatory or licensing agency from another licensing jurisdiction;

(2) The most recent inspection report that is less than two years old that demonstrates applicable compliance with this rule by the national association of boards of pharmacy's verified pharmacy program;

(3) The most recent inspection report that is less than two years old that demonstrates applicable compliance with this rule conducted by accreditation commission for health care inspection services (a.k.a. ACHC inspection services or AIS);

(4) Proof of a current pharmacy compounding accreditation board (PCAB) accreditation provided by the accreditation commission for health care (ACHC); or

(5) Proof of a current medication compounding certification from the joint commission.

(I) A pharmacy licensed as a nonresident terminal distributor shall report to the state board of pharmacy within seventy-two hours upon discovery, and in a manner determined by the board, any product quality issue attributed to a compounded drug preparation dispensed by the pharmacy.

(1) As used in this paragraph, a product quality issue means any of the following:

(a) Any incident that causes the compounded drug preparation or its labeling to be mistaken for, or applied to, another article;

(b) Contamination of the compounded drug preparation, including but not limited to mold, fungal, bacterial, or particulate contamination; or

(c) Any significant chemical, physical, or other change or deterioration of the dispensed compounded drug preparation within the compounded drug preparation's assigned beyond use date.

(2) A product quality issue does not include an isolated allergic reaction to a substance included in a compounded drug preparation.

(J) A pharmacy licensed as a nonresident terminal distributor shall report to the state board of pharmacy within seventy-two hours of issuance or receipt, and in a manner determined by the board, any warning letters, injunctions, or decrees issued in relation to the pharmacy by the United States food and drug administration.

(K) This rule does not apply to a pharmacy licensed as a nonresident terminal distributor of dangerous drugs that prepares radiopharmaceuticals as defined in agency 4729 of the Administrative Code.

Last updated July 1, 2021 at 11:12 AM

History

Effective: July 1, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-8-05 Preparation, compounding, dispensing, and repackaging of radiopharmaceuticals by a nonresident pharmacy.

(A) Except as otherwise provided in this rule, terms used in this rule have the same meaning as in rule 4729:5-6-01 of the Administrative Code.

(B) Only a pharmacy licensed as a nonresident terminal distributor of dangerous drugs may dispense or sell patient-specific radiopharmaceuticals into this state and shall comply with all the following:

(1) All radiopharmaceuticals shall be dispensed pursuant to a patient-specific prescription or order issued by a licensed health professional authorized to prescribe drugs.

(a) A limited quantity may be prepared and distributed in anticipation of prescriptions based on routine, regularly observed prescribing patterns.

(b) In the event a patient's name is not available at the time of dispensing, a nonresident nuclear pharmacy shall have up to seventy-two hours to obtain the name of the patient. No later than seventy-two hours after dispensing the radiopharmaceutical, the patient's name must be associated with the prescription in the dispensing records maintained by the nonresident pharmacy.

(2) Comply with the requirements of USP <825>.

(3) Shall have an authorized nuclear pharmacist licensed in this state as its responsible person. The requirement for the responsible person to obtain Ohio licensure shall take effect on June 30, 2022.

(1) In addition to the requirements in paragraph (C) of this rule, the outer shielding shall also be labeled with the following:

(a) The name and telephone number of the pharmacy;

(b) The prescription number; and

(c) The patient's name (first name and last name or first initial and last name), if available at the time of dispensing.

(2) In addition to the requirements in paragraph (C) of this rule, the immediate container shall also be labeled with the following information:

(a) The prescription number; and

(b) The patient's name (first name and last name or first initial and last name), if available at the time of dispensing.

(D) A pharmacy licensed as a nonresident terminal distributor shall ensure that all employees comply with all applicable local, state, and federal requirements for the proper labeling, environmental controls, integrity, and safety of all products transported.

(E) A pharmacy licensed as a nonresident terminal distributor shall ensure that all employees comply with all applicable local, state, and federal requirements for the disposal of radioactive and/or biohazardous waste in a manner so as not to endanger the health and safety of the public.

(F) A terminal distributor shall report any event as a medical event, except for an event that results from patient intervention, to the United States nuclear regulatory commission in accordance with 10 CFR 35.3045 (6/2/2020).

(G) A pharmacy licensed as a nonresident terminal distributor shall report to the state board of pharmacy, within seventy-two hours and in a manner determined by the board, any warning letters, injunctions, or decrees issued by the United States food and drug administration or any other federal or state agency.

(H) If a pharmacy is applying for an initial nonresident terminal distributor of dangerous drugs license, renewal, or their license has lapsed, the pharmacy shall provide any of the following, in a manner determined by the board, as part of the initial or renewal application:

(1) The most recent inspection report that is less than two years old that demonstrates applicable compliance with USP <825> conducted by an agent of the regulatory or licensing agency in the pharmacy's resident jurisdiction or an agent of a regulatory or licensing agency from another licensing jurisdiction;

(2) The most recent inspection report that is less than two years old that demonstrates applicable compliance with USP <825> rule by the national association of boards of pharmacy's verified pharmacy program; or

(3) Any other documentation of compliance as determined by the state board of pharmacy.

(I) This rule does not apply to a pharmacy licensed as a nonresident terminal distributor of dangerous drugs that prepares compounded drug preparations in accordance with rule 4729:5-8-04 of the Administrative Code.

Last updated February 1, 2022 at 9:18 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Chapter 4729:5-9 Institutional Facilities

Ohio Adm.Code 4729:5-9-01 Definitions.

As used in Chapter 4729:5-9 of the Administrative Code:

(A) "Institutional facility" means any of the following:

(1) A public hospital or hospital as defined in section 3701.01 or 5122.01 of the Revised Code.

(2) A freestanding emergency department.

(3) A freestanding inpatient rehabilitation facility or inpatient rehabilitation facility as defined in rule 3701-83-25 of the Administrative Code.

(4) An ambulatory surgical facility as defined in rule 3701-83-15 of the Administrative Code.

(5) A nursing home licensed under Chapter 3721. of the Revised Code;

(6) An inpatient psychiatric service provider as defined in rule 5122-14-01 of the Administrative Code;

(7) A facility that provides medically supervised detoxification services that meets the following requirements:

(a) Patients are administered dangerous drugs to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of drugs or alcohol;

(b) Patients are under the care of a licensed prescriber and are provided continuous onsite monitoring by nurses licensed in accordance with Chapter 4723. of the Revised Code;

(c) If the period of detoxification is less than twenty-four hours, patients shall be transitioned to an inpatient, residential, or outpatient treatment program; and

(d) The facility holds the appropriate license or certification by the Ohio department of mental health and addiction services.

(8) A residential care facility licensed under Chapter 3721. of the Revised Code that provides skilled nursing care to its residents, including medication administration as authorized in Chapter 3701-16 of the Administrative Code, provided the facility meets the following requirements:

(a) The administration of medication shall be in compliance with this chapter and Chapter 3701-16 of the Administrative Code, including the requirement to maintain individual medication records and documentation of medication orders; and

(b) The residential care facility maintains an executed contract or agreement with an institutional pharmacy for the provision of institutional pharmacy services. The executed contract or agreement shall be maintained in a readily retrievable manner.

(9) A state or local correctional facility, as defined in section 5163.45 of the Revised Code;

(10) A juvenile correctional facility that is under the management and control of the department of youth services or a private entity with which the department of youth services has contracted for the institutional care; and

(11) Any other facility as determined by the board.

(B) "Institutional pharmacy" means a pharmacy that primarily provides inpatient pharmacy services to an institutional facility in accordance with this chapter.

(C) "Audit trail" means all materials and documents required for the entire processing of a prescription, which shall be sufficient to document or reconstruct the origin of the prescription order, and authorization of subsequent modifications of that order.

(D) "Automated drug storage system" means a mechanical system used for the secure storage of dangerous drugs used as floor stock or contingency drugs outside of an institutional pharmacy that collects, controls, and maintains transaction information and records.

(E) "Contingency drugs" are a supply of non-patient specific dangerous drugs which may be required to meet the therapeutic needs of patients or staff when either apply:

(1) The institutional facility's on-site pharmacy is closed or otherwise unavailable to provide pharmacy services;

(2) The institutional facility does not have an on-site pharmacy.

(F) "Dispense" means the final association of a drug with a particular patient pursuant to a prescription, medication order, or other lawful order of a prescriber and the professional judgment of and the responsibility for interpreting, preparing, compounding, labeling, and packaging a specific drug.

In the case of an automated drug storage system meeting the requirements of rule 4729:5-9-03.4 of the Administrative Code, the final association with the name of a particular inpatient will be deemed to have occurred when the pharmacist has given final approval to the patient specific order in the system.

(G) "Electronic drug record keeping system" means a system of storing drug records electronically and, when required, capturing positive identification.

(H) "Inpatient" means any person who receives drugs for use while within an institutional facility.

(J) "Medication order" or "inpatient prescription" means a written, electronic, facsimile, or oral order for a drug to be dispensed or administered in treating an inpatient.

(K) "OARRS report" means a report of information related to a specific person generated by the drug database established and maintained pursuant to section 4729.75 of the Revised Code.

(L) "Outpatient" means any person who receives drugs for use outside of an institutional facility.

(M) "Medications removed on override function" or "override medications" means a dangerous drug that may be removed from floor stock or contingency drugs prior to pharmacist review because the institutional facility's interdisciplinary committee has determined that the clinical status of the patient would be compromised by delay.

(N) "Personal supervision" or "direct supervision" means a pharmacist shall be physically present in the pharmacy, or in the area where the practice of pharmacy is occurring, and provides personal review and approval of all professional activities.

(O) "Personally furnish" or "personally furnishing" means the final association of a drug with a patient by a prescriber prior to the distribution to a patient for use outside an institutional facility. A prescriber at an institutional facility who personally furnishes a dangerous drug shall comply with the requirements of rule 4729:5-19-02 of the Administrative Code.

(P) "Pharmacist" means an individual who holds a current pharmacist license under Chapter 4729. of the Revised Code.

(Q) "Pharmacy," except when used in a context that refers to the practice of pharmacy, means any area, room, rooms, place of business, department, or portion of any of the foregoing where the practice of pharmacy is conducted.

(R)

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier for entry into a secure mechanical or electronic system.

(S) "Point of care location" means a location within an institutional facility that stores dangerous drugs and all the following apply:

(1) The point of care location is licensed as a terminal distributor of dangerous drugs;

(2) The dangerous drugs are not owned by the institutional facility where the point of care location is located;

(3) The dangerous drugs stored are owned by another institutional facility licensed as a terminal distributor of dangerous drugs; and

(4) The location may be used for the administration, personally furnishing, or dispensing of dangerous drugs, including controlled substances.

(T) "Practice of pharmacy" has the same meaning as in division (B) of section 4729.01 of the Revised Code.

(U) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(V) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

(W) "Skilled nursing care" has the same meaning as in section 3721.01 of the Revised Code.

(X) "Tamper-evident" means a package, storage container or other physical barrier is sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

Last updated February 1, 2022 at 9:19 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02 Institutional pharmacies.

An institutional pharmacy as defined in rule 4729:5-9-01 of the Administrative Code shall comply with all requirements of this rule, including all supplemental rules adopted thereunder.

Last updated February 1, 2022 at 9:21 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.1 Minimum standards for institutional pharmacies.

(A) Library

(1) All pharmacists working in an institutional pharmacy must be able to access all current federal and state laws, regulations, and rules governing the legal distribution of drugs in Ohio, including internet access to the following:

(a) The board's website;

(b) LAWriter Ohio laws and rules (http://codes.ohio.gov);

(c) The code of laws of the United States of America (variously abbreviated to Code of Laws of the United States, United States Code, U.S. Code, U.S.C., or USC); and

(d) The code of federal regulations.

(2) The pharmacy shall have access to and utilize the references necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and to comply with all state and federal laws, this shall include hard copy or internet access to appropriate pharmacy reference materials.

(3) A pharmacy engaged in the compounding of dangerous drugs shall have access to all references listed in rule 4729:7-1-01 of the Administrative Code.

(4) All pharmacists working in a pharmacy shall have access to the telephone number of a poison control center.

(B) Equipment

The pharmacy shall carry and utilize the equipment necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and to comply with all state and federal laws.

The stock of drugs shall include such chemicals, drugs, and preparations sufficient to compound and prepare all types of prescriptions offered by the pharmacy.

(D) Space and fixtures

(1) All areas where drugs, equipment, and devices are stored and prepared shall be dry, well-lit, well-ventilated, and maintained in a clean, sanitary, and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the drugs prior to their dispensing or administering as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(2) All storage areas shall provide adequate security for all dangerous drugs in accordance with the requirements of rule 4729:5-9-02.2 of the Administrative Code.

(E) Personnel

(1) The pharmacy shall be appropriately staffed to operate in a safe and effective manner pursuant to section 4729.55 of the Revised Code.

(2) An employee of a pharmacy must be identified by a name tag that includes the employee's job title.

(F) Quality assurance

The institutional pharmacy shall implement quality assurance program that is designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, prevention and detection of drug diversion, and resolve identified problems.

Last updated February 1, 2022 at 9:21 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.2 Security, storage and control of dangerous drugs in an institutional pharmacy.

(A) All areas of an institutional pharmacy shall be capable of being secured by key, or other effective mechanism, to prevent access by unauthorized personnel.

(1) Except as provided in paragraph (C)(5) of this rule and rule 4729:5-9-03.1 of the Administrative Code, only a licensed pharmacist may have access to keys, alarm codes, or other methods of gaining access to the pharmacy when the pharmacy is closed.

(2) Keys to the pharmacy maintained on-site that are not in the possession of a licensed pharmacist shall be secured to prevent unauthorized access.

(3) All combinations or access codes, including alarm codes, shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(B) Except as provided in rules 4729:5-9-02.10 and 4729:5-9-03.1 of the Administrative Code, a pharmacist shall provide supervision of the dangerous drugs, exempt narcotics, D.E.A. controlled substance order forms, and all records relating to the distribution of dangerous drugs, except where the board has granted a permission for such records to be stored at a secure off-site location in accordance with this chapter, at all times in order to deter and detect theft or diversion.

(C) Except as provided in rule 4729:5-9-02.10 of the Administrative Code, in the absence of a licensed pharmacist, an institutional pharmacy must be secured by either:

(1) A physical barrier (i.e. barricade) with suitable locks approved by the board. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board of any installation or modification to a physical barrier prior to implementation.

(2) An alarm system approved by the board that is monitored by a central station for control and can detect unauthorized access to the pharmacy. The alarm system shall be tested on a biannual basis. The pharmacy or the entity that manages security for the pharmacy shall maintain testing records for three years from the date of testing and shall make such records readily retrievable. The pharmacy shall be responsible for obtaining testing records if such records are maintained by a third-party. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board of any installation or modification to an alarm system prior to implementation. This notification requirement does not apply if a pharmacy also utilizes an approved physical barrier in accordance with paragraph (C)(1) of this rule.

(3) Except as provided in paragraph (C)(5) of this rule and rule 4729:5-9-03.1 of the Administrative Code, only a pharmacist may have access to an institutional pharmacy or stock of dangerous drugs or assume responsibility for the security of dangerous drugs, hypodermics, and any other item or product that requires the supervision or sale by a pharmacist.

(4) All schedule II controlled substance dangerous drugs shall be stored in a securely locked, substantially constructed cabinet or safe and shall not be dispersed through the stock of dangerous drugs. The cabinet or safe shall remain locked and secured when not in use. Schedule III through V controlled substance dangerous drugs may be stored with Schedule II controlled substance dangerous drugs.

(5) Any designated area located outside an institutional pharmacy at the location licensed as a terminal distributor of dangerous drugs intending to be used for the storage of D.E.A. controlled substance order forms, records relating to the distribution of dangerous drugs, except where the board has granted a permission for such records to be stored at a secure off-site location pursuant to this chapter of the Administrative Code, shall be secured by an physical barrier with suitable locks to detect unauthorized entry.

(6) Dangerous drugs maintained outside of an institutional pharmacy but located on the premises of an institutional facility shall comply with the security and control requirements set forth in this chapter of the Administrative Code.

(D) Refrigerators and freezers used for the storage of dangerous drugs by an institutional pharmacy shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The pharmacy shall develop and implement policies and procedures to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The pharmacy shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs.

(E) In accordance with section 3719.172 of the Revised Code, an institutional pharmacy shall develop and implement policies to prevent hypodermics from theft or acquisition by any unauthorized person.

(F) Adulterated drugs, including expired drugs, shall be stored in accordance with rule 4729:5-3-06 of the Administrative Code.

(G) Disposal of non-controlled dangerous drugs shall be conducted in accordance with rule 4729:5-3-06 of the Administrative Code.

(H) Disposal of controlled substance dangerous drugs shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code.

(I) Upon the initial puncture of a multiple-dose vial containing a drug, the vial shall be labeled with a beyond-use date or date opened. The beyond-use date for an opened or entered (e.g., needle punctured) multiple-dose container with antimicrobial preservatives is twenty-eight days, unless otherwise specified by the manufacturer. A multiple-dose vial that exceeds its beyond-use date shall be deemed adulterated.

Last updated February 1, 2022 at 9:22 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.3 Record keeping at an institutional pharmacy.

(A) An institutional pharmacy shall document, using positive identification, the licensed or registered individuals responsible for performing the following activities authorized under Chapter 4729. of the Revised Code and agency 4729 of the Administrative Code:

(1) Medication order or prescription information entered into the record keeping system. This provision shall take effect one-year from the effective date of this rule.

(2) Verification by the pharmacist of the prescription information entered into the record keeping system.

(3) Drug utilization review in accordance with rule 4729:5-9-02.6 of the Administrative Code, which shall be captured as a standalone action or as part of either:

(a) The pharmacist verification of prescription information as required by paragraph (A)(2) of this rule; or

(b) The dispensing process in paragraph (A)(4) of this rule.

(4) Dispensing, except that a pharmacist shall not be required to perform a check of dangerous drugs prior to distribution if the drug is dispensed in accordance with either:

(a) Paragraph (F)(5) of this rule; or

(b) In accordance with rule 4729:5-3-17 of the Administrative Code.

(5) Compounding in accordance with Chapter 4729:7-2 of the Administrative Code.

(6) Administering immunizations pursuant to section 4729.41 of the Revised Code.

(7) Administering other injectable drugs pursuant to section 4729.44 of the Revised Code.

(8) Prescription information transcribed from an order received by telephone or recording device.

(9) Any changes or annotations made to a prescription or medication order.

(B) An institutional pharmacy shall maintain the following records:

(1) All medication orders issued in accordance with rule 4729:5-9-02.7 of the Administrative Code.

(2) Records of drugs dispensed shall including all the following:

(a) The name, strength, dosage form, route of administration, and quantity of drugs dispensed;

(b) The date of dispensing;

(d) The positive identification of the individuals involved in the dispensing process in accordance with paragraph (A)(1) of this rule.

(C) An institutional pharmacy shall maintain records of all drugs dispensed to outpatients pursuant to rule 4729:5-5-04 of the Administrative Code.

(D) An institutional pharmacy shall maintain records of all drugs repackaged pursuant to rule 4729:5-9-02.12 of the Administrative Code.

(E) An institutional pharmacy shall maintain records of all drugs compounded pursuant to Chapter 4729:7-2 of the Administrative Code.

(F) An institutional pharmacy shall maintain records for the distribution of non-patient specific dangerous drugs to other areas of the institutional facility for administration or use, which shall include all the following:

(1) The name, strength, dosage form, and amount of drug distributed.

(2) The area receiving the drug.

(3) The date distributed.

(4) Except as provided in paragraph (F)(5) of this rule, the positive identification of the pharmacist checking the dangerous drugs prior to distribution. Such documentation shall be maintained for a period of three years in a manner that is readily retrievable.

(5) A pharmacist shall not be required to perform a check of dangerous drugs prior to distribution if all the following apply:

(a) The drugs are distributed in accordance with paragraph (A)(2)(a) of rule 4729:5-3-17 of the Administrative Code.

(b) The drugs are stored or will be stored in an automated drug storage system that utilizes barcode system to track and correctly identify drugs stored within the system.

(c) A pharmacist has conducted an initial check of every barcode to ensure they have been assigned correctly to the appropriate drug. The initial check shall be documented using positive identification and maintained for a period of three years in a manner that is readily retrievable.

(d) The pharmacy develops and implements a policy that includes all the following:

(i) Verification by a pharmacist, documented using positive identification, prior to any changes to barcodes, additions to the formulary, or modification of a drug's national drug code (NDC). Any change shall be documented using positive identification and maintained for a period of three years in a manner that is readily retrievable.

(ii) Requiring a pharmacist to document using positive identification the addition of auxiliary barcodes to drugs. Such documentation shall be maintained for a period of three years in a manner that is readily retrievable.

(iii) A process to immediately alert the pharmacy of an error resulting from an incorrect barcode or a barcode override to ensure the accuracy of the system.

(iv) Prohibits a pharmacy technician or pharmacy intern from moving or modifying any barcodes inside the system. Any modifications may only be done by a pharmacist and shall be documented using positive identification. Such documentation shall be maintained for a period of three years in a manner that is readily retrievable.

(6) For non-controlled dangerous drugs: the identification of the facility personnel receiving the drug or authorized personnel stocking the automated drug storage system.

(7) For controlled substance dangerous drugs: the positive identification of the facility personnel receiving the drug or authorized personnel stocking the automated drug storage system.

(G) Records of receipt of dangerous drugs shall contain the name, strength, dosage form, and quantity of the dangerous drugs received, the name and address of the seller, the name and address of the recipient, and the date of receipt.

(H) Records of temperature control monitoring described in paragraph (D) of rule 4729:5-9-02.2 of the Administrative Code shall include any of the following:

(1) For temperature logs, either:

(a) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(b) For systems that provide automated temperature monitoring, maintain a report that provides, at a minimum, the date and time of observation and the temperature recorded.

(2) For temperature monitoring systems capable of detecting and alerting staff of a temperature excursion, maintain reports that provide information on any temperature excursion that includes the date, time, temperature recorded, and length of each excursion.

(I) Records of dangerous drugs disposed from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and, if disposal is performed on-site, the positive identification of the licensed health care professional that performed the disposal.

(J) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory is performed on-site in an institutional pharmacy, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal, one of whom shall be a pharmacist.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient in an institutional pharmacy, records shall also include the positive identification of two licensed or registered healthcare professionals conducting and witnessing the disposal.

(K) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

(L) Records of transfers to other terminal distributors of dangerous drugs, including sales conducted in accordance with rule 4729:5-3-09 of the Administrative Code, shall contain the name, strength, dosage form, and quantity of the dangerous drug transferred, the address of the location where the drugs were transferred and the date of transfer.

(M) All institutional pharmacy records required in accordance with this chapter shall be maintained under appropriate supervision and control to restrict unauthorized access.

(N) All institutional pharmacy records maintained in accordance with this chapter shall be uniformly maintained for a period of three years. Except as provided in paragraph (N)(3) of this rule, all records shall be made readily retrievable.

(1) Computerized drug record keeping systems or subsequent storage of such records, must be retrievable via digital display, hard copy printout, or other mutually agreeable transfer medium.

(2) If a computerized drug record keeping system is being utilized, the method(s) of achieving positive identification must be approved, in a manner determined by the board, prior to implementation or any subsequent modification.

(3) Record keeping systems shall provide immediate retrieval via digital display and hard copy printout or other mutually agreeable transfer medium of information for all prescriptions, or medication orders, dispensed within the previous twelve months, and shall provide in a manner that is readily retrievable information on all prescriptions dispensed beyond the previous twelve months but within the previous three years.

(4) All computerized record keeping systems shall be able to capture records edited by authorized personnel and maintain an audit trail as defined in rule 4729:5-9-01 of the Administrative Code.

(5) All paper records maintained electronically shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user.

(6) All computerized record keeping systems, including systems used to store scanned paper records, shall have daily back-up functionality to protect against record loss and security features to prevent unauthorized access.

(O)

(1) Except as provided for in paragraph (O)(2) of this rule, all records maintained in accordance with this chapter shall be maintained on-site.

(2) An institutional pharmacy located in this state intending to maintain records at a location other than the location licensed by the state board of pharmacy shall send a request in a manner determined by the board. The board will provide written or electronic notification to the institutional pharmacy documenting the approval or denial of the request. A copy of the board's approval shall be maintained at the licensed location. Any such alternate location used to store records shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

Last updated February 1, 2022 at 9:20 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.4 Dispensing of controlled substances by an institutional pharmacy.

All controlled substances dispensed in quantities exceeding a seventy-two-hour supply shall be packaged in tamper-evident, unit-of-use containers except when unit-of-use packaging is not available including, but not limited to, multi-dose liquids and injectables.

Last updated February 1, 2022 at 9:22 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.5 Patient profiles.

All institutional pharmacies shall maintain a patient profile system which shall provide for immediate retrieval of information regarding those patients who have received medications from that pharmacy.

(A) All patient profile systems shall maintain, at a minimum, the following data:

(1) The patient's data record, which shall consist of, but is not limited to, the following information:

(a) Full name of the patient for whom the drug is intended.

(b) Patient's date of birth.

(d) A list of current patient specific data consisting of at least the following, if made known to the pharmacist or agent of the pharmacist:

(i) Drug related allergies;

(ii) Previous drug reactions;

(iii) History of or active chronic conditions or disease states; and

(iv) Other drugs, including nonprescription drugs, devices and nutritional supplements used on a routine basis.

(e) The pharmacist's comments relevant to the individual patient's drug therapy, including any other necessary information unique to the specific patient or drug.

(2) The patient's drug therapy record, which shall contain the following information for all medications dispensed by the pharmacy within the last twelve months.

(a) The original medication order;

(b) Date and time of issuance of the medication order by the prescriber;

(d) The prescriber's credential (MD, NP, PA, etc.);

(e) Directions for use;

(f) The proprietary name, if any, or the generic name and the name of the distributor or national drug code of the drug or device dispensed; and

(g) The strength, dosage form, route of administration, and quantity of the drug or device dispensed.

(B) An institutional pharmacy shall make a reasonable effort to obtain a patient's medical history necessary to conduct a prospective drug utilization review.

Last updated February 1, 2022 at 9:22 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.6 Pharmacist drug utilization review.

(A) Except as provided in paragraph (F) of this rule, prior to dispensing any initial medication order or medication order change, a pharmacist shall conduct a prospective drug utilization review of the patient profile for the purpose of identifying the following:

(1) Over-utilization or under-utilization of medications dispensed in the institutional facility;

(2) Therapeutic duplication;

(3) Drug-disease state contraindications;

(4) Drug-drug interactions;

(5) Incorrect drug dosage;

(6) Drug-allergy interactions;

(7) Abuse/misuse;

(8) Inappropriate duration of drug treatment; and

(9) Food-nutritional supplements-drug interactions.

(1) Requesting and reviewing an OARRS report or another state's prescription drug monitoring report;

(2) Consulting with the prescriber; or

(3) Counseling the patient.

(C) Prospective drug utilization review shall be performed using predetermined standards consistent with, but not limited to, any of the following:

(2) American hospital formulary service drug information; and

(3) United States pharmacopeia drug information.

(D) Based upon information obtained during a prospective drug utilization review, a pharmacist shall use professional judgment when making a determination about safe and appropriate use and the legitimacy of a medication order. A pharmacist shall not dispense a dangerous drug from a medication order or prescription of doubtful, questionable, or suspicious origin.

(E) The requirement to conduct a prospective drug utilization review in accordance with paragraph (A) of this rule does not apply to drugs personally furnished or administered from floor stock, contingency drugs, or an automated drug storage system in either of the following circumstances:

(1) A prescriber controls the ordering, preparing, and administering of the drug; or

(2) Delay would harm the patient.

(F) A pharmacist shall conduct a retrospective review of medication orders within a reasonable amount time and make a determination about the safe and appropriate use and the legitimacy of the order in either of the following circumstances:

(1) Any drug removed from the pharmacy or contingency stock in accordance with rule 4729:5-9-03.01 of the Administrative Code; and

(2) The use of override medications as defined in paragraph (M) of rule 4729:5-9-01 of the Administrative Code.

(G) An institutional facility shall develop and implement policies and procedures to require pharmacists to report unsafe or inappropriate prescribing or dosing by prescribers to the appropriate oversight committee.

Last updated February 1, 2022 at 9:23 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.7 Medication orders for inpatients and outpatient prescriptions.

(A) Dangerous drugs shall be dispensed by a pharmacist for inpatients pursuant to an original patient-specific order issued by a prescriber or a protocol or pre-printed order as authorized in accordance with rule 4729:5-3-12 of the Administrative Code. All controlled substance prescriptions or medication orders shall be issued in accordance with 21 CFR part 1306 (7/1/2019) and 21 CFR part 1311 (7/1/2019).

(1) Medication orders for inpatients of an institutional facility transmitted to a pharmacy by use of an electronic drug record keeping system may be considered an original order for the dispensing of drugs. Access to such system for entering and transmitting original orders shall be restricted to personnel authorized in accordance with written policies and procedures of the institutional facility. If the authorized personnel entering the order into the system is not the prescriber, there shall be a system in place requiring the positive identification of the prescriber for each order within a reasonable period of time which shall be made readily retrievable.

(2) Oral orders issued by a prescriber for inpatients of an institutional facility may be transmitted to a pharmacist by personnel authorized in accordance with written policies and procedures of the institutional facility. Such orders shall be transcribed by the pharmacist, noting the full name(s) of the authorized personnel transmitting the order. Oral orders issued by a prescriber and transmitted by authorized personnel shall be verified by the prescriber using positive identification within a reasonable time and as required by the written policies and procedures of the facility.

Authorized personnel at an institutional facility may transcribe an oral order of a prescriber, including those received telephonically, in accordance with rule 3701-16-09 or 3701-17-13 of the Administrative Code and transmit the written transcription to the pharmacy by facsimile machine or electronic prescription transmission system in accordance with written policies and procedures of the institutional facility. The transcribed order shall include the positive identification of the authorized facility personnel who transcribed and transmitted the order to the pharmacy.

(a) Oral orders for non-controlled substances issued by a prescriber for inpatients of an institutional facility may be transmitted to a pharmacy intern by personnel authorized by, and in accordance with, written policies and procedures of the facility if the pharmacist on duty who is personally supervising the activity of the intern determines that the intern is competent to perform this function.

(i) The intern shall immediately transcribe the order, document the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent and shall review the order with the pharmacist on duty. Prior to dispensing, positive identification of the intern and the pharmacist on duty shall be recorded to identify the responsibility for the receipt of the oral order.

(ii) The pharmacist on duty is responsible for the accuracy of the prescription.

(iii) The pharmacist on duty must be immediately available to answer questions or discuss the prescription with the prescriber or the prescriber's agent.

(b) Oral orders for non-controlled substances issued by a prescriber for inpatients of an institutional facility may be transmitted to a certified pharmacy technician in pursuant to rule 4729:3-3-04 of the Administrative Code by personnel authorized by, and in accordance with, written policies and procedures of the facility. Oral orders issued by a prescriber and transmitted by authorized personnel shall be verified by the prescriber using positive identification within a reasonable time and as required by the written policies and procedures of the facility.

(3) Medication orders for inpatients of an institutional facility transmitted to a pharmacy by use of a facsimile machine shall be transmitted by personnel authorized by, and in accordance with, written policies and procedures of the facility.

Telephonic orders transcribed by authorized residential care facility personnel and transmitted to a pharmacy by use of a facsimile machine shall comply with the requirements of rule 3701-16-09 or 3701-17-13 of the Administrative Code and the policies and procedures of the institutional facility.

A facsimile shall only be valid as an order if a pharmacy retains a printed copy of a facsimile prescription or an electronic copy of the facsimile prescription in accordance with paragraph (B) of this rule.

(B) All non-controlled hard copy medication orders, including facsimiles, may be electronically maintained, provided that the system creates and maintains electronic records in accordance with the following:

(1) All hard copy medication orders for non-controlled dangerous drugs may be electronically filed and then destroyed after one hundred and eighty days from the date of creation or receipt. Disposal of the hard copy shall use a secure method of destruction to ensure privacy and confidentiality of the contents.

(2) All hard copy medication orders electronically filed in accordance with this rule shall be scanned front and back in full color (i.e. retains color information and/or color graphics in the document) via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user. Prior to scanning, the written or faxed order shall be clearly notated to indicate it has been received by the pharmacy in a manner that does not destroy any of the original information contained on the prescription but prevents the unauthorized duplication of the prescription.

(4) The electronic form shows the exact and legible image of the original hard copy medication order.

(5) All hard copy orders filed electronically in accordance with this rule shall be deemed the original prescription.

(1) Name of patient;

(2) Name, strength, and dosage form of drug;

(3) Directions for use, including route of administration;

(4) Date prescribed;

(5) The ordering prescriber's positive identification, which may be maintained in the patient's medical record at the institutional facility; and

(6) If applicable, the positive identification of the authorized individual transmitting the order on behalf of the prescriber.

(D) An institutional pharmacy shall develop and maintain written stop order policies or other methods of assuring that drug orders are not continued inappropriately in accordance with the status of the patient.

(E) Drugs may be dispensed for outpatients by an institutional pharmacy pursuant to an original prescription of a prescriber in accordance with rule 4729:5-5-15 of the Administrative Code. All outpatient prescriptions dispensed by an institutional pharmacy shall comply with the following outpatient pharmacy requirements:

(1) Labeling requirements in accordance with rule 4729:5-5-06 of the Administrative Code;

(2) Record keeping requirements in accordance with rule 4729:5-5-04 of the Administrative Code;

(3) Patient counseling requirements pursuant to rule 4729:5-5-09 of the Administrative Code;

(4) Prescription filing requirements pursuant to rule 4729:5-5-03 of the Administrative Code;

(5) Manner of processing requirements pursuant to rule 4729:5-5-10 of the Administrative Code;

(6) Serial numbering requirements pursuant to rule 4729:5-5-13 of the Administrative Code;

(7) Pick-up station requirements pursuant to rule 4729:5-5-14 of the Administrative Code;

(8) Patient profile requirements pursuant to rule 4729:5-5-07 of the Administrative Code;

(9) Reporting of all drugs pursuant to division 4729:8 of the Administrative Code; and

(10) Prospective drug utilization review requirements pursuant to rule 4729:5-5-08 of the Administrative Code.

(F) Outpatient prescriptions may be transferred by an inpatient pharmacy to an outpatient pharmacy in accordance with rule 4729:5-5-11 of the Administrative Code.

(G) A pharmacist may modify an outpatient prescription pursuant to rule 4729:5-5-16 of the Administrative Code.

(H) An original signed prescription for a schedule II controlled substance prepared in accordance with federal and state requirements and issued for a resident in a long-term care facility may be transmitted by the prescriber or the prescriber's agent to the dispensing pharmacy by facsimile. The facsimile shall serve as the original written prescription and shall be received and maintained pursuant to rules 4729:5-5-10 and 4729:5-5-15 of the Administrative Code. The original signed prescription must remain with the patient's records at either the prescriber's office or the long-term care facility.

(I) A prescription or medication order, to be valid, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of the prescriber's professional practice. The responsibility for the proper prescribing is upon the prescriber, but a corresponding responsibility rests with the pharmacist who dispenses the prescription. An order purporting to be a prescription issued not in the usual course of bona fide treatment of a patient is not a prescription and the person knowingly dispensing such a purported prescription, as well as the person issuing it, shall be subject to the penalties of law.

(J) A pharmacy providing emergency kits for use by a nursing home or residential care facility pursuant to rule 4729:5-9-03.1 of the Administrative Code must receive a valid outpatient prescription issued in accordance with rule 4729:5-5-15 of the Administrative Code prior to the administration of the initial dose of a controlled substance drug contained in the kit. The pharmacy providing the emergency kit shall be responsible for generating and maintaining a record of the dispensing of the initial dose of a controlled substance drug obtained from the kit in compliance with the record keeping requirements set forth in rule 4729:5-9-02.3 of the Administrative Code.

Last updated February 1, 2022 at 9:20 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.8 Labeling of prescriptions for patients.

(A) All dangerous drugs dispensed for use by inpatients in an institutional facility, whereby the drug is not in the possession of the ultimate user prior to administration, shall meet the following requirements:

(1) The label of a single unit package of an individual-dose or unit-dose system of packaging of drugs shall include:

(a) The non-proprietary or proprietary name of the drug;

(b) Dosage form and route of administration;

(d) The control number and expiration date;

(e) National drug code, universal product code, or formulary code, if applicable, which may be embedded in a barcode or quick response (QR) code on the label;

(f) Identification of the manufacturer, packer or distributor, or, if the repackager is the dispensing pharmacy, identification of the repackager shall be by name or by the final seven digits of their terminal distributor of dangerous drugs license number, and such identification shall be clearly distinguishable from the rest of the label; and

(g) Special storage conditions, if required.

(2) At least the name of the patient must be placed on all medication containers too small to bear a complete label and dispensed in a container bearing a complete label.

(B) All drugs dispensed to inpatients for self-administration or dispensed for outpatient use shall be labeled in accordance with rule 4729:5-5-06 of the Administrative Code.

(1) The patient's full name;

(2) The name and amount of the parenteral solution;

(3) The name and amount of the drug(s) added;

(4) The expiration date or beyond-use date;

(5) The name and address of the institutional pharmacy;

(6) Cautionary statements, if required.

(D) Supplemental labels created by a pharmacy that contain a barcode or QR code for the purpose of identifying a drug shall contain a means of identifying the positive identification of the pharmacist responsible for:

(1) Association of the barcode to the drug product;

(2) Association of the label to the drug product.

Last updated February 1, 2022 at 9:23 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.9 Licensure of outpatient institutional pharmacies.

(A) As used in this rule, "outpatient institutional pharmacy" means a pharmacy located within or on the campus of an institutional facility that provides outpatient pharmacy services which is physically separate from, and not contiguous to, the area in which inpatient pharmacy services are provided.

(B) An outpatient institutional pharmacy shall have a separate terminal distributor of dangerous drugs license in addition to the license for the institutional facility or pharmacy. An outpatient institutional pharmacy shall comply with the requirements of Chapter 4729:5-5 of the Administrative Code.

Last updated February 1, 2022 at 9:24 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.10 Temporary absence of a pharmacist in an institutional pharmacy.

(A) A pharmacist practicing within an institutional facility may temporarily leave the pharmacy to engage in the practice of pharmacy within the institutional facility without closing the pharmacy and removing staff from the pharmacy if the practicing pharmacist can ensure there are adequate security measures and policies to maintain the security of the drug stock in the pharmacist's absence.

(B) If in the pharmacist's professional judgment they determine, for reasons of security or otherwise, that the pharmacy should close during the pharmacist's absence, then the pharmacist shall close the pharmacy and remove all staff from the pharmacy during the pharmacist's absence.

(C) During the pharmacist's absence, no dangerous drugs shall be dispensed unless the pharmacist has conducted a final association of the drug with a patient and has complied with all other applicable rules prior to dispensing a dangerous drug.

(D) During such times that the pharmacist is temporarily absent from the pharmacy, the pharmacy staff may continue to perform the non-discretionary duties authorized in accordance with Chapter 4729. of the Revised Code and agency 4729 of the Administrative Code. However, any duty performed by any member of the staff shall be reviewed by the pharmacist upon the pharmacist's return to the pharmacy.

(E) The institutional facility shall have written policies and procedures regarding the operation of the pharmacy during the temporary absence of the pharmacist. The policies and procedures shall include the authorized duties of pharmacy staff, the pharmacist's responsibilities for checking all work performed by staff, and the pharmacist's responsibility for maintaining the security and control of the drug stock.

(F) Unless otherwise authorized in agency 4729 of the Administrative Code, this rule does not permit non-pharmacist personnel from having unsupervised access to drug stock when an institutional pharmacy is closed.

Last updated February 1, 2022 at 9:24 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.11 Dispensing customized patient medication packages by an institutional pharmacy.

In lieu of dispensing two or more dangerous drugs in separate containers, a pharmacist practicing at an institutional pharmacy may dispense a customized patient medication package. A customized patient medication package is a package for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms that complies with the following requirements:

(A) The package is designed, or each container is labeled, to indicate the day and time or period of time when the contents within each container are to be taken by the patient.

(B) The number of drugs placed in each container cannot exceed the capability of the container to prevent damage to the dosage forms.

(D) The labels must be of sufficient size to properly and clearly label a thirty-one-day or less supply with all information required in accordance with this chapter of the Administrative Code, including the use of accessory labels. When a customized medication packaging is utilized, including dispensing of single unit packages, the drugs shall be dispensed in a container or package with an affixed label containing the following information:

(1) Identification of the dispensing pharmacy;

(2) The patient's full name;

(3) The date of dispensing;

(4) The non-proprietary and/or proprietary name of the drug;

(5) National drug code, universal product code, or formulary code, if applicable, which may be embedded in a barcode or quick response (QR) code on the label;

(6) The strength of the drug;

(7) The pharmacy's expiration date or beyond-use date, which shall not exceed the expiration date on the manufacturer's container or six months from the date the drug was originally packaged, whichever date is earlier. If multiple manufacturer containers are used, the expiration date shall not exceed the expiration date on the manufacturer's container that will expire first or six months from the date the drug was originally repackaged, whichever date is earlier.

(E) All drugs dispensed to inpatients for self-administration or dispensed for outpatient use shall also be labeled in accordance with rule 4729:5-5-06 of the Administrative Code.

(F) Dangerous drugs which have been dispensed in a customized patient medication package may only be returned to stock or re-dispensed in accordance with all the following:

(1) The drugs have not been in the possession of the ultimate user; and

(2) The drugs have not been placed in the same container with another dangerous drug (i.e. did not come into direct contact with a different drug within the same container).

(G) The containers of a package are sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

(1) The U.S.P. monograph or official labeling requires dispensing in the original container, unless there is documentation from the manufacturer stating otherwise;

(2) The drugs or dosage forms are incompatible with packaging components or each other;

(3) The drugs are therapeutically incompatible when administered simultaneously;

(4) The drugs require special packaging.

Last updated February 1, 2022 at 9:24 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.12 Drugs repackaged or relabeled by an institutional pharmacy.

(B) The following rule applies to dangerous drugs repackaged by an institutional pharmacy. The rule does not apply to any of the following:

(1) Repackaging drug products for use in animals;

(2) Repackaging non-dangerous drug products;

(3) Radiopharmaceuticals as defined in Chapter 4729:5-6 of the Administrative Code;

(4) Repackaging conducted by outsourcing facilities or repackagers licensed in accordance with section 4729.52 of the Revised Code;

(6) Upon receipt of, or in anticipation of, a valid patient-specific prescription or medication order, a licensed pharmacy removing from one container the quantity of non-sterile drug products (e.g., oral dosage forms) necessary to fill the prescription and placing it in a different container to dispense directly to the patient; and

(7) Investigational new drugs being studied under an investigational new drug application.

(1) Unless otherwise specified in the individual monograph or in the absence of stability data to the contrary, the beyond-use date shall be not later than the expiration date on the manufacturer's container or one-year from the date the drug is repackaged, whichever is earlier. Sterile compounded drug preparations shall comply with paragraph (C)(2) of this rule.

(2) Sterile compounded drug preparations shall comply with United States pharmacopeia chapter <797> as referenced in rule 4729:7-1-01 of the Administrative Code.

(D) Labels of drugs repackaged by and stored within a pharmacy prior to being dispensed shall contain, but not be limited to, the following:

(1) Name of drug, strength, and dosage form;

(2) National drug code or universal product code, if applicable, which may be embedded in a barcode or quick response (QR) code on the label;

(3) The identification of the repackager by name or by the final seven digits of their terminal distributor of dangerous drugs license number;

(4) Pharmacy control number; and

(5) The beyond-use date of the repackaged drug in accordance with the guidance listed in paragraph (C) of this rule.

(E) All drugs dispensed to inpatients for self-administration or dispensed for outpatient use shall also be labeled in accordance with rule 4729:5-5-06 of the Administrative Code.

(F) A record of all drugs repackaged and stored within a pharmacy prior to being dispensed shall be kept for at least three years or one year past manufacturer's expiration date, whichever is greater. This record shall include, at a minimum, the following:

(1) Name of drug, strength, dosage form, and quantity;

(2) National drug code or universal product code (UPC), if applicable, which may be embedded in a barcode or quick response (QR) code on the label;

(3) Manufacturer's or distributor's control number;

(4) Manufacturer's or distributor's name, if a generic drug is used, or if not using NDC or UPC;

(5) Pharmacy control number;

(6) Manufacturer's or distributor's expiration date;

(7) The pharmacy's beyond-use date in accordance with the guidance listed in paragraph (C) of this rule;

(8) The positive identification of the individual responsible for the repackaging of the drug; and

(G) Supplemental labels created by a pharmacy that contain a barcode or QR code for the purpose of identifying a drug shall contain a means of identifying the positive identification of the pharmacist responsible for:

(1) Association of the barcode to the drug product;

(2) Association of the label to the drug product.

Last updated February 1, 2022 at 9:25 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.13 Institutional central fill pharmacies.

(A) As used in this chapter:

(1) "Central fill pharmacy" means a pharmacy licensed as a terminal distributor of dangerous drugs acting as an agent of an originating pharmacy to fill or refill a medication order. A central fill pharmacy may be used to replenish automated drug storage systems and automated pharmacy systems.

(2) "Originating pharmacy" means an institutional pharmacy licensed as a terminal distributor of dangerous drugs that uses a central fill pharmacy to fill or refill medication order. A central fill pharmacy may be used to replenish automated drug storage systems and automated pharmacy systems.

(B) A central fill pharmacy and originating pharmacy may process a request for the filling or refilling of a medication order received by an originating pharmacy pursuant to the following requirements:

(2) The central fill pharmacy shall maintain a record of all originating pharmacies, including name, address, terminal distributor number, and, if applicable, drug enforcement administration registration number, for which it processes a request for the filling or refilling of a medication order received by the originating pharmacy. The record shall be made readily retrievable and maintained for a period of three years.

(4) The originating pharmacy shall comply with the minimum required information for a patient profile pursuant to rule 4729:5-9-02.5 of the Administrative Code prior to sending a medication order to the central fill pharmacy.

(6) The prescription label attached to the container shall contain the name and address of the originating pharmacy and the name of the central fill pharmacy. If applicable, the date on which the medication order was dispensed shall be the date on which the central fill pharmacy filled the order.

(7) The originating pharmacy shall maintain the original of all medication orders received for purposes of filing and record keeping as required by state and federal law, rules, and regulations.

(8) The central fill pharmacy shall maintain all original fill and refill requests received from the originating pharmacy and shall treat them as original and refill medication orders for purposes of filing and record keeping as required by state and federal law, rules, and regulations.

(9) The central fill pharmacy and originating pharmacy shall each maintain records to capture the positive identification of the licensed or registered individuals responsible for performing respective activities in accordance with rule 4729:5-9-02.3 of the Administrative Code.

(10) The central fill pharmacy and originating pharmacy shall adopt a written quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, resolve identified problems, and ensure compliance with this rule. The quality assurance plan shall be reviewed and updated annually.

(C) Dangerous drugs may be returned by the originating pharmacy to the central fill pharmacy for the purpose of being returned to the central fill pharmacy's stock shelves in accordance with the following:

(1) The central fill pharmacy complies with the requirements of rule 4729:5-3-16 of the Administrative Code; and

(2) The originating and central fill pharmacy are under common ownership and control.

(D) An originating pharmacy may return dangerous drugs received by a central fill pharmacy to stock shelves in accordance with rule 4729:5-3-16 of the Administrative Code.

(E) All written documentation required by this rule shall be maintained for three years from the date of execution or review and shall be made readily retrievable.

(F) An institutional pharmacy may utilize a central fill pharmacy to dispense outpatient prescriptions in accordance with rule 4729:5-5-19 of the Administrative Code.

(G) Drugs that are repackaged or relabeled by a central fill pharmacy shall comply with the requirements of rule 4729:5-9-02.12 of the Administrative Code.

Last updated February 1, 2022 at 9:25 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.14 Remote medication order processing.

(A) As used in this rule:

(1) "Remote medication order processing" means the processing of a medication order for an institutional pharmacy licensed as a terminal distributor of dangerous drugs by a remote pharmacist. Remote medication order processing does not include the dispensing of a drug, but may include receiving, interpreting, evaluating, clarifying, and approval of medication orders. Additionally, remote medication order processing may include order entry, other data entry, performing prospective drug utilization review, interpreting clinical data, performing therapeutic interventions, providing drug information services, and authorizing release of the medication for administration. The requirements of this rule shall be limited to the processing of medication orders dispensed in or into this state.

(2) "Remote pharmacy" means either:

(a) A pharmacy licensed as a terminal distributor of dangerous drugs that dispenses dangerous drugs; or

(3) "Remote pharmacist" means any of the following:

(a) If performing remote medication order processing in this state: an Ohio licensed pharmacist, either employed or a contract employee of an institutional pharmacy or remote pharmacy, who either processes orders from a remote site, which may include the pharmacist's residence or other location where the pharmacist and the institutional or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or institutional pharmacy; or

(b) If performing remote medication order processing outside of this state: a pharmacist licensed or registered in the state where the remote medication order processing is occurring, either employed or a contract employee of an institutional pharmacy or remote pharmacy who holds a nonresident pharmacy license in accordance with Chapter 4729:5-8 of the Administrative Code, who either processes prescriptions from a remote site, which may include the pharmacist's residence or other location where the pharmacist and the institutional or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or institutiona pharmacy.

A pharmacist shall only be permitted to conduct remote medication order processing within the United States, to include the District of Columbia, the Commonwealth of Puerto Rico or a territory or insular possession subject to the jurisdiction of the United States.

(B) An institutional pharmacy may outsource medication order processing to a remote pharmacy provided the pharmacies are under common ownership or control or the institutional pharmacy has entered into a written contract or agreement with a pharmacy that outlines the services to be provided and the responsibilities and accountabilities of each party to the contract or agreement in compliance with federal and state law, rules, and regulations.

(C) The institutional pharmacy and remote pharmacy must maintain a copy of the contract or agreement in a readily retrievable manner for inspection and review by an agent, inspector, or employee of the board.

(D) An institutional pharmacy utilizing remote medication order processing shall ensure that all remote pharmacists providing such services have been trained on the institutional pharmacy's policies and procedures relating to medication order processing. The training of each pharmacist shall be documented.

(1) Such training shall include, but is not limited to, policies on drug and food allergy documentation, abbreviations, administration times, automatic stop orders, substitution, and formulary compliance. The institutional pharmacy and the remote pharmacy shall jointly develop a procedure to communicate changes in policies and procedures related to medication order processing.

(2) A terminal distributor of dangerous drugs may utilize one training program for all institutional pharmacies under the terminal distributor's common ownership and control.

(E) An institutional pharmacy utilizing remote pharmacists shall maintain or have access to a record of the name and license number of each pharmacist, evidence of current pharmacist licensure in the state where the pharmacist is performing remote order processing, and the address of each location where the pharmacist will be providing remote medication order processing services.

(F) An institutional pharmacy shall ensure that any remote pharmacist shall have secure electronic access to the institutional pharmacy's patient information system and to other electronic systems that the on-site pharmacist has access to when the pharmacy is open.

(G) The remote pharmacist must be able to contact the prescriber issuing a medication order to discuss any concerns identified during the pharmacist's review of patient information and the medication order. A procedure must be in place to communicate any problems identified with the prescriber and the nursing staff providing direct patient care.

(H) Each remote entry record must comply with all record keeping requirements for institutional pharmacies, including capturing the positive identification of the remote pharmacist involved in the review and verification of the medication order.

(I) An institutional pharmacy utilizing remote medication order processing is responsible for maintaining records of all medication orders entered into their information system, including orders entered by a remote pharmacist. The system shall have the ability to audit the activities of the remote pharmacists.

(J) An institutional pharmacy utilizing remote medication order processing services shall develop and implement a policy and procedure manual. A remote pharmacy shall maintain a copy of those portions of the policy and procedure manual that relate to the remote pharmacy's operations. Each manual shall include all the following:

(1) Outline the responsibilities of the institutional pharmacy and the remote pharmacy;

(2) Include a list of the names, addresses, telephone numbers, and all license numbers of the pharmacies/pharmacists involved in remote medication order processing; and

(3) Include policies and procedures for:

(a) Protecting the confidentiality and integrity of patient information;

(b) Ensuring that no patient information is duplicated, downloaded, or removed from the institutional pharmacy's patient information system;

(d) Complying with federal and state law, rules, and regulations;

(e) Reviewing written policies and procedures at least every three years, or upon the implementation of a significant change of written policies and procedures, and documentation of the review; and

(f) Annually reviewing the competencies of pharmacists providing remote order entry processing services.

Last updated November 30, 2021 at 8:29 AM

History

Effective: November 30, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-02.15 Remote order entry - technicians.

(A) As used in this rule:

(1) "Direct supervision" and "personal supervision" have the same meaning as in rule 4729:3-1-01 of the Administrative Code.

(2) "Remote order entry" means the entry of medication orders for an inpatient pharmacy licensed as a terminal distributor of dangerous drugs by a remote technician under the direct supervision or remote supervision of a pharmacist. Remote order entry does not include dispensing, interpreting, evaluating, or approval of medication orders or any other activities not permitted by state or federal laws, rules, and regulations. Remote order entry may include clarifying orders and other data entry, including the processing of insurance coverage. The requirements of this rule shall be limited to the entry of orders dispensed in or into this state.

(3) "Remote pharmacy" means either:

(a) A pharmacy licensed as a terminal distributor of dangerous drugs that dispenses dangerous drugs; or

(a) Be readily available to answer questions of a remote technician; and

(b) Be fully responsible for the practice and accuracy of the remote technician.

(5) "Remote technician" means any of the following:

(a) If performing remote order entry in this state: an Ohio registered certified pharmacy technician, registered pharmacy technician, or pharmacy technician trainee, either employed or a contract employee of an inpatient pharmacy or remote pharmacy, who either conducts order entry from a remote site, which may include the technician's residence or other location where the technician and the outpatient or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or institutional pharmacy; or

(b) If performing remote order entry outside of this state: a pharmacy technician who meets the following criteria:

(i) The pharmacy technician licensed or registered in the state where the remote order entry is occurring, or if working in a state that has not yet implemented a technician registration process, has received training and is working as a pharmacy technician in accordance with of the laws and regulations of their state of practice; and

(ii) The pharmacy technician is either employed or a contract employee of an institutional pharmacy or remote pharmacy who holds a nonresident pharmacy license in accordance with Chapter 4729:5-8 of the Administrative Code, who either conducts order entry from a remote site, which may include the technician's residence or other location where the technician and the outpatient or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or institutional pharmacy.

(c) A nonresident pharmacy shall be responsible for ensuring all actions performed by an unregistered technician comply with the applicable requirements for conducting remote order entry.

(d) A remote technician shall only be permitted to conduct remote order entry within the United States, to include the District of Columbia, the Commonwealth of Puerto Rico or a territory or insular possession subject to the jurisdiction of the United States.

(B) An institutional pharmacy may outsource order entry to a remote pharmacy provided the pharmacies are under common ownership or control or the institutional pharmacy has entered into a written contract or agreement with a pharmacy that outlines the services to be provided and the responsibilities and accountabilities of each party to the contract or agreement in compliance with federal and state statutes and regulations.

(C) The inpatient pharmacy and remote pharmacy must maintain a copy of the contract or agreement in a readily retrievable manner for inspection and review by an agent, inspector, or employee of the board.

(D) An inpatient pharmacy utilizing remote order entry shall ensure that all remote technicians providing such services have been trained on the inpatient pharmacy's policies and procedures relating to order entry.

(1) The training of each remote technician shall be documented. The inpatient pharmacy and the remote pharmacy shall jointly develop a procedure to communicate changes in policies and procedures related to order entry.

(2) A terminal distributor of dangerous drugs may utilize one training program for all inpatient pharmacies under the terminal distributor's common ownership and control.

(E) An inpatient pharmacy utilizing remote technicians shall maintain or have access to a record of the name and address of each technician, evidence of current licensure or registration, and the address of each location where the technician will be providing remote order entry services.

(F) The inpatient pharmacy shall ensure that any remote technician shall have secure electronic access to the inpatient pharmacy's patient information system and to other electronic systems that an on-site technician has access to when the pharmacy is open.

(G) Each remote entry record must comply with all recordkeeping requirements for inpatient pharmacies, including capturing the positive identification of the remote technician involved in the entry of the medication order.

(H) An inpatient pharmacy utilizing remote order entry is responsible for maintaining records of all orders entered into their information system, including orders entered by a remote technician.

(I) An inpatient pharmacy utilizing remote order entry services shall develop and implement a policy and procedure manual. A remote pharmacy shall maintain a copy of those portions of the policy and procedure manual that relate to the remote pharmacy's operations. Each manual shall include all the following:

(1) An overview of the responsibilities of the inpatient pharmacy and the remote pharmacy;

(2) A list of the names, addresses, telephone numbers, and all license numbers of the pharmacies and remote technicians involved in remote order entry; and

(3) Policies and procedures for:

(a) Protecting the confidentiality and integrity of patient information;

(b) Ensuring that no patient information is duplicated, downloaded, or removed from the inpatient pharmacy's patient information system;

(d) Complying with federal and state statutes and regulations; and

(e) Reviewing written policies and procedures at least every three years or upon the implementation of a significant change of written policies and procedures and documentation of the review.

(J) A pharmacy intern that is licensed in this or any other state may engage in remote order entry pursuant to the requirements of this rule.

Last updated November 30, 2021 at 8:29 AM

History

Effective: November 30, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-03 Institutional facilities.

An institutional facility as defined in rule 4729:5-9-01 of the Administrative Code shall comply with all requirements of this rule, including all supplemental rules adopted thereunder.

Last updated February 1, 2022 at 9:26 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-03.1 Contingency drugs in an institutional facility and emergency access to an institutional pharmacy.

In the absence of an available on-site pharmacy, drugs prescribed for patient treatment in an institutional facility may be obtained in the following manner:

(A) Contingency drugs, as defined in rule 4729:5-9-01 of the Administrative Code, may be made available to licensed health care professionals authorized pursuant to the Revised Code to administer drugs during the professional's practice.

(B) An institutional facility maintaining contingency drugs shall hold a license, which may include a campus license, as a terminal distributor of dangerous drugs.

(1) The institutional pharmacy maintains a terminal distributor of dangerous drugs license on behalf of the institutional facility.

(2) The institutional pharmacy and institutional facility maintain an executed contract or agreement outlining the services to be provided and the responsibilities of each party in fulfilling the terms of the contract or agreement in compliance with federal and state law, rules, and regulations. The executed contract or agreement shall be maintained in a readily retrievable manner.

(D) An institutional facility with an on-site pharmacy, including institutional facilities under a campus license, shall develop and implement a policy whereby a licensed pharmacist shall be made available for emergencies when the institutional pharmacy is closed. The pharmacist may be made available via telephone or other form of electronic communication.

(E) Contingency drugs shall be stored in accordance with the security requirements of rule 4729:5-9-03.2 of the Administrative Code.

(F) The entity holding the terminal distributor of dangerous drugs license for an institutional facility's contingency stock shall:

(1) Designate personnel who are authorized to access to the contingency drug supply;

(2) Determine, in conjunction with the appropriate interdisciplinary committees, the drugs that are to be included in the contingency drug supply;

(3) Ensure that such drugs are properly labeled and packaged in amounts sufficient for the immediate treatment of patients;

(4) Ensure the security and control of the contingency drugs in accordance with the requirements set forth in paragraph (E) of this rule;

(5) Institute record keeping procedures to comply with the requirements set forth in rule 4729:5-9-03.3 of the Administrative Code;

(6) Develop and implement procedures for the inspection of the contingency drug inventory to ensure proper utilization and replacement of the drug supply; and

(7) Comply with all applicable requirements for dangerous drugs in accordance Chapter 4729:5-9 of the Administrative Code and all other requirements for holding a terminal distributor of dangerous drugs license in accordance with agency 4729 of the Administrative Code.

(G) An institutional facility may maintain an emergency kit (e-kit) containing controlled substances provided by a licensed pharmacy to withdraw medication to treat the immediate needs of a patient until patient-specific controlled substance medication is physically delivered to the facility by the pharmacy. If a multi-dose medication is removed from the emergency kit, it shall be labeled to include the patient's name.

(1) The pharmacy providing the emergency kit must receive a valid outpatient prescription issued in accordance with rule 4729:5-5-15 of the Administrative Code prior to the administration of medication removed from the kit.

(2) The pharmacy providing the emergency kit shall be responsible for generating and maintaining a record of the dispensing of the medication obtained from the kit in compliance with the record keeping requirements set forth in rule 4729:5-9-02.3 of the Administrative Code.

(3) The institutional facility and institutional pharmacy shall comply with all other state and federal requirements for controlled substances maintained in emergency kits (e-kit).

(H) If a dangerous drug is not available from the contingency drug stock and such drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, the drug may be obtained from an on-site institutional pharmacy pursuant to written policies and procedures adopted by the terminal distributor of dangerous drugs. The policies and procedures shall:

(1) Identify the personnel authorized to access the pharmacy and the conditions under which access may be gained to the pharmacy.

(2) Ensure a minimum of two employees of the institutional facility, one of whom shall be a prescriber or nurse licensed pursuant to Chapter 4723. of the Revised Code, to accompany and witness the activity of each other when accessing the pharmacy.

(3) Provide a written or electronic record documenting emergency access to the pharmacy. Such record shall include the names, titles, and positive identification of all institutional personnel accessing the pharmacy, date and time of access, the name and quantity of drugs obtained, the name of the patient, and the name of the ordering prescriber. Such records shall be maintained for three years and made readily retrievable.

(4) The written or electronic record of each access to the institutional pharmacy made in accordance with paragraph (H)(3) of this rule shall be filed no later than the next business day with the institutional facility's responsible person or the responsible person's designee and maintained by the institutional pharmacy for three years.

(I) An institutional pharmacy may be accessed in the event of a fire, flood, natural disaster, or other exigent circumstance pursuant to written policies and procedures adopted by the terminal distributor of dangerous drugs. The policies and procedures shall:

(1) Identify the personnel authorized to access the pharmacy and the conditions under which access may be gained to the pharmacy.

(3) Provide a written or electronic record documenting emergency access to the pharmacy. Such record shall include the names, titles, and positive identification of all institutional personnel accessing the pharmacy, and the date and time of access. If dangerous drugs are removed from the pharmacy, the name and quantity of drugs removed, the name of the patient (if applicable), and the name of the ordering prescriber (if applicable). Such records shall be maintained for three years and made readily retrievable.

(4) The written or electronic record of each access to the institutional pharmacy made in accordance with paragraph (I)(3) of this rule shall be filed no later than the next business day with the institutional facility's responsible person or the responsible person's designee and maintained by the institutional pharmacy for three years.

Last updated February 1, 2022 at 9:26 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-03.2 Security, storage and control of dangerous drugs in an institutional facility.

(A) As used in this rule, "blind count" means a physical inventory taken by a person authorized by the institutional facility's responsible person who performs a physical inventory without knowledge of or access to the quantities currently shown on electronic or other inventory systems.

(B) Except as provided in this rule, all non-controlled dangerous drugs, including those dispensed by an institutional pharmacy to inpatients, shall be stored in a secure area to deter and detect unauthorized access.

(C) Non-controlled dangerous drug emergency or contingency kits may be secured using a tamper-evident method. Drugs stored using a tamper-evident method shall be routinely inspected to detect unauthorized access in accordance with a policy developed by the facility. The policy shall be made readily retrievable.

(D) All controlled substance dangerous drugs, including those dispensed by an institutional pharmacy to inpatients, maintained in areas outside of the institutional pharmacy that are not stored as part of an automated drug storage system, shall meet the following requirements, unless stored as part of an automated drug storage system that meets the requirements of paragraph (E) of this rule:

(1) The drugs shall be a securely locked in a substantially constructed cabinet or safe to deter and detect unauthorized access.

(2) At every change of shift, a reconciliation shall be conducted by both the departing and incoming licensed health care professional responsible for the security and control of the drugs in the area in which they are stored and shall include the following:

(a) A physical count and reconciliation of the controlled substances and proof-of-use sheets or electronic records to ensure the accountability of all doses;

(b) An inspection of the packaging to ensure its integrity;

(d) The immediate reporting of any unresolved discrepancy to the appropriate personnel within the institution, including the responsible person or the responsible person's designee.

(e) Paragraph (D)(2)(a) of this rule does not apply to emergency or contingency drug kits secured using a tamper-evident method.

(3) All controlled substances shall be packaged in tamper-evident containers, except multi-dose liquids and injectables where unit-of-use packaging is not available.

(4) Maintain a record keeping system for each drug in accordance with rule 4729:5-9-03.3 of the Administrative Code.

(E) All controlled substance dangerous drugs, including those dispensed by an institutional pharmacy to inpatients, maintained in areas outside of the institutional pharmacy that are stored in an automated drug storage system shall meet the following requirements:

(1) All controlled substances stored in automated drug storage systems shall be limited to one drug and strength at a time.

(2) For automated drug storage systems that cannot limit access to one dose at a time, authorized personnel shall conduct a blind count each time a controlled substance is removed from the system.

(3) The automated drug storage system shall be securely locked and substantially constructed to deter and detect unauthorized access.

(4) The system shall document the positive identification of every person accessing the system and shall record the date and time of access.

(5) The institutional facility shall maintain a recordkeeping system in accordance with rule 4729:5-9-03.3 of the Administrative Code.

(6) At least annually, the responsible person shall cause a reconciliation of all controlled substances within an automated drug storage system to be conducted. The reconciliation shall include the following:

(a) A physical count and reconciliation of the controlled substances to ensure the accountability of all doses;

(b) An inspection of the packaging to ensure its integrity;

(d) The immediate reporting of any unresolved discrepancy to the appropriate personnel within the institution, including the responsible person or the responsible person's designee.

(F) Access to controlled substances shall be restricted to health care professionals authorized pursuant to the Revised Code to administer controlled substances as part of the professional's scope of practice.

(G) All areas where dangerous drugs are stored shall be dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the drugs prior to use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Refrigerators and freezers used for the storage of drugs shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs.

(H) In accordance with section 3719.172 of the Revised Code, an institutional facility shall develop and implement policies to prevent hypodermics from theft or acquisition by any unauthorized person.

(I) Adulterated drugs, including expired drugs, shall be stored in accordance with rule 4729:5-3-06 of the Administrative Code.

(J) Disposal of non-controlled dangerous drugs shall be conducted in accordance with rule 4729:5-3-06 of the Administrative Code.

(K) Disposal of controlled substance dangerous drugs shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code.

(L) Upon the initial puncture of a multiple-dose vial containing a drug, the vial shall be labeled with a beyond-use date or date opened. The beyond-use date for an opened or entered (e.g., needle punctured) multiple-dose container with antimicrobial preservatives is twenty-eight days, unless otherwise specified by the manufacturer. A multiple-dose vial that exceeds its beyond-use date shall be deemed adulterated.

(M) Uncompleted prescription blanks shall be secured when not in use and access shall be limited to personnel authorized in policy by the institutional facility.

(N) Personnel authorized by the responsible person may have access to D.E.A. controlled substance order forms only under the personal supervision of a prescriber. D.E.A. controlled substance order forms shall be secured when not in use.

Last updated January 23, 2023 at 8:54 AM

History

Effective: January 23, 2023
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-03.3 Record keeping in an institutional facility.

This rule applies to records for dangerous drugs, including those dispensed by an institutional pharmacy to inpatients, maintained in areas outside of the institutional pharmacy by an institutional facility.

(A) An institutional facility shall maintain a record of all dangerous drugs administered to patients that includes all the following information:

(1) Name of the patient;

(2) Name, strength, dosage form, route of administration, and quantity of the dangerous drugs administered;

(3) Date and time the dangerous drugs were administered;

(4) The positive identification of the person removing the dangerous drug for patient administration;

(5) Positive identification of the personnel administering the drug; and

(6) For controlled substance dangerous drugs:

(a) If removed from a secured location, the positive identification of the person removing the controlled substance for patient administration; and

(b) The disposal of an unused portion of a controlled substance conducted in accordance with paragraph (J) of rule 4729:5-9-03.2 of the Administrative Code.

(B) Records of dangerous drugs personally furnished at an institutional facility shall contain the name, strength, dosage form, and quantity of the dangerous drugs personally furnished, the name, address and date of birth of the person to whom or for whose use the dangerous drug were personally furnished, the positive identification of the prescriber personally furnishing the drug, the date the drug is personally furnished and, if applicable, the date the drug is received by the patient or patient's caregiver.

(C) Records of receipt shall contain the name, strength, dosage form, and quantity of the dangerous drugs received, the name and address of the seller, the name and address of the recipient, and the date of receipt.

(D) Records of transfers to other terminal distributors of dangerous drugs, including sales conducted in accordance with rule 4729:5-3-09 of the Administrative Code, shall contain the name, strength, dosage form, and quantity of the dangerous drug transferred, the address of the location where the drugs were transferred and the date of transfer.

(E) Records of temperature control monitoring described in paragraph (F) of rule 4729:5-9-03.2 of the Administrative Code shall include any of the following:

(1) For temperature logs, either:

(a) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(b) For systems that provide automated temperature monitoring, maintain a report that provides, at a minimum, the date and time of observation and the temperature recorded.

(F) Records of dangerous drugs disposed from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, the positive identification of the licensed health care professional that performed the disposal.

(G) Records of dangerous drugs administered by a health care professional, acting within the professional's scope of practice, who is not a prescriber shall include documentation of an order issued by a prescriber or protocol authorizing the administration of the drug. An order that is a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph. Orders for the administration of dangerous drugs shall be documented using positive identification. All orders for drugs for inpatients shall include the following:

(1) Name of patient;

(2) Name, strength, and dosage form of drug;

(3) Directions for use, including route of administration;

(4) Date prescribed; and

(5) The ordering prescriber's positive identification.

(H) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory is performed on-site, records shall also include the positive identification of two licensed healthcare professionals conducting and witnessing the disposal, one of whom shall be the responsible person or the responsible person's designee.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient, records shall also include the positive identification of two licensed healthcare professionals conducting and witnessing the disposal.

(I) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

(J) All records required in accordance with this chapter shall be maintained under appropriate supervision and control to restrict unauthorized access.

(K) All records maintained in accordance with this rule shall be readily retrievable and shall be kept on-site for a period of three years.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(L) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) Complies with the requirements of this rule;

(2) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features, such as unique user names and passwords, to prevent unauthorized access; and

(4) Contains daily back-up functionality to protect against record loss.

Last updated February 1, 2022 at 9:27 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-03.4 Automated drug storage systems in an institutional facility.

All automated drug storage systems utilized by an institutional facility shall comply with the following:

(A) Except as provided in paragraph (B) of this rule, the computer program used to access all drugs within the automated drug storage system shall have an electronic timeout of sixty seconds of inactivity.

(B) For an automated drug storage system used exclusively for administering anesthesia drugs that is under the immediate supervision of a licensed healthcare provider authorized to administer such drugs, the computer program used to access all drugs within the automated drug storage system shall have an electronic timeout of no more than sixty minutes of inactivity, unless an alternative method to ensure the security of the drug stock is approved by the board.

(C) The institutional facility shall develop and implement policies and procedures for all automated drug storage systems that include the following:

(1) Provide for a written or electronic record documenting access to the automated drug storage system. Such record shall include the names, titles, and positive identification of all personnel accessing medications, date and time of access, the name and quantity of drugs obtained, and the name of the patient. All records shall be maintained in accordance with paragraphs (K) and (L) of rule 4729:5-9-03.3 of the Administrative Code.

(2) Provide security controls to prevent diversion of the drugs.

(3) Develop policies and procedures to track access to emergency override access keys.

(4) Provide procedures for the inspection of the systems to ensure proper utilization and replacement of the drug supply.

(5) If override medications are utilized, the institutional facility shall develop and implement a policy that describes the types of medication overrides that will be reviewed for appropriateness and the frequency of the reviews.

(6) All policies and procedures required in accordance with this paragraph shall be maintained in a readily retrievable manner.

Last updated February 1, 2022 at 9:28 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-03.5 Hospital self-service employee prescription kiosks.

(A) As used in this rule:

(1) "Hazardous drug" means any drug listed in table one on the national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the Administrative Code.

(2) "Hospital" means a public hospital or hospital as defined in section 3701.01 or 5122.01 of the Revised Code.

(3) "Self-service employee prescription kiosk" or "kiosk" means a self-service kiosk for the pickup of new or refill prescriptions only for hospital employees and their family members.

(B) A self-service employee prescription kiosk shall meet all the security requirements of this rule and be located either:

(1) On the campus of a hospital licensed as a terminal distributor of dangerous drugs and located in the immediate proximity of a pharmacy, unless otherwise approved by an agent of the board; or

(2) At a location that is licensed as a terminal distributor of dangerous drugs that not located on the campus of a hospital but is owned by the hospital.

(C) Only a dangerous drug prescription dispensed by a hospital-owned pharmacy may be provided to the patient or employee representative of the patient via a self-service kiosk. A kiosk shall not provide any of the following:

(1) Any drug that must be refrigerated; or

(2) Any hazardous drug, except for conventionally manufactured hazardous drugs that are tablets or capsules that do not require any further manipulation other than counting or repackaging.

(D) A kiosk located in accordance with paragraph (B)(2) of this rule shall be placed in an area that is restricted to hospital employees and is secured by both a physical barrier with suitable locks and an electronic barrier to detect unauthorized entry.

(E) All kiosks shall be continuously monitored by one or more video cameras that possess the capability of having its picture recorded. The video camera(s) shall provide one hundred percent video coverage of the kiosk. Camera recordings shall be maintained for at least ninety days and shall made available within three business days of a request by an agent of the state board of pharmacy. The kiosk location must have adequate lighting to produce clear digitally recorded and still picture production.

(F) A kiosk shall only be stocked by a hospital employed pharmacist, pharmacy intern, certified pharmacy technician, registered pharmacy technician or pharmacy technician trainee.

(G) A dispensing pharmacy described in paragraph (C) of this rule shall maintain an appropriate recordkeeping system that will provide accountability for proper receipt of all prescriptions provided to a patient or employee representative of the patient via a self-service kiosk.

(H) A kiosk shall employ a method of two-factor authentication to identify a patient or employee representative of the patient such that a finished prescription is delivered from a kiosk only to its intended recipient.

(I) A kiosk must prominently display notification that patient counseling is available pursuant to rule 4729:5-5-09 of the Administrative Code. Counseling may be provided by a pharmacist reachable at a toll-free telephone number who has access to the patient profile. Instructions on how to contact a pharmacist via toll-free telephone must be displayed by the kiosk and must also be printed on the customer receipt or included with the patient instructions.

(J) A self-service employee prescription kiosk shall meet all the following:

(1) Is electronically protected against unauthorized access;

(2) Be bolted to the floor or installed in a wall;

(3) Be constructed in such manner as to prevent tampering, break-in and theft of inventory; and

(4) Is able to either:

(a) Sound an alarm if a break-in is attempted; or

(b) Transmit a notification to on-site security if a break-in is attempted.

(K) Prior to the deployment of a kiosk, the responsible person at the location licensed as a terminal distributor of dangerous drugs shall test the kiosk to ensure that it releases drugs properly. The responsible person shall monitor performance of the kiosk on an ongoing basis and test the kiosk for accuracy whenever any change or upgrade is made.

(L) All drugs and devices in a kiosk shall be maintained in a clean and orderly condition. Kiosks shall be maintained at temperatures which will ensure the integrity of the drugs as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(M) Dangerous drugs stored in a kiosk that are not picked up by a patient may be returned to stock shelves in accordance with rule 4729:5-3-16 of the Administrative Code.

(N) Prior to the operation of a kiosk, the board shall receive a request for approval from the responsible person on the terminal distributor of dangerous drugs license. Upon notification, the board shall conduct an inspection of the area where the kiosk shall be located and review system specifications to determine if it meets the requirements of this rule.

(O) If an inspection does not result in the approval of a kiosk, the responsible person named on the terminal distributor of dangerous drugs license may request an in-person meeting with the board to appeal the denial.

Last updated February 1, 2022 at 9:28 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-9-03.6 Point of care locations in an institutional facility.

(A) "Point of care location" has the same meaning as in rule 4729:5-9-01 of the Administrative Code.

(B) Dangerous drugs maintained at a point of care location shall be in a securely locked, substantially constructed cabinet, including an automated drug storage system, or safe to deter and detect unauthorized access.

(C) The responsible person for the point of care location shall be an employee of the institutional pharmacy that owns the drug stock and shall be responsible for all the following:

(1) Designating those who may obtain access to the drug stock;

(2) Determining, in conjunction with the appropriate interdisciplinary committees, the drugs that are to be included at the point of care location;

(3) Providing controls to prevent the diversion of the drug stock;

(4) Instituting record keeping procedures to account for drugs removed from the point of care location and for capturing the positive identification of the person who obtained the drugs from the point of care location; and

(5) Providing procedures for the inspection of the point of care location to ensure proper utilization and replacement of the drug stock.

(D) If dangerous drugs that are controlled substances are stored at the point of care location, the owner of the drug stock shall either:

(1) Obtain a drug enforcement administration (DEA) registration for the point of care location; or

(2) Utilize the DEA registration of the institutional facility where the point of care location is located. The institutional facility where the point of care location is located shall be responsible for compliance with all federal and state laws, rules, and regulations relating to the possession and use of controlled substances.

(E) This rule does not apply to pharmacy-supplied contingency drugs in an institutional facility licensed as a terminal distributor of dangerous drugs.

(F) An institutional point of care location shall comply with the requirements of rules 4729:5-9-03.2 and 4729:5-9-03.3 of the Administrative Code.

Last updated June 25, 2025 at 5:47 PM

History

Effective: January 23, 2023
Promulgated Under: 119.03

Chapter 4729:5-10 Drug Repositories

Ohio Adm.Code 4729:5-10-01 Definitions - drug repository programs.

As used in Chapter 4729:5-10 of the Administrative Code:

(A) "Charitable pharmacy" has the same meaning as in section 3719.811 of the Revised Code.

(B) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(C) "Distributor of dangerous drugs" or "drug distributor" has the same meaning as in rule 4729:6-1-01 of the Administrative Code.

(D) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(E) "Drug repository program" means a program authorized to accept prescription drugs donated or given for the purpose of being dispensed or personally furnished to individuals who are residents of this state and meets eligibility standards established in this chapter.

(F) "Hospital" has the same meaning as in section 3727.01 of the Revised Code.

(G) "Institutional facility" has the same meaning as defined in agency 4729 of the Administrative Code.

(H) "Licensed health care professional" has the same meaning as in section 3715.872 of the Revised Code.

(I) "Nonprofit clinic" has the same meaning as in section 3715.87 of the Revised Code.

(J) "Orally administered cancer drug" means either of the following:

(1) An orally administered dangerous drug that is used to treat cancer or its side effects; or

(2) An orally administered dangerous drug that is used to treat the side effects of a dangerous drug used to treat cancer.

(K) "Original sealed and tamper-evident unit dose packaging" includes single unit dose packaging of oral medications from a manufacturer or a repackager registered with the federal food and drug administration, or from a pharmacy and includes injectables, topicals, and aerosols in the manufacturer's or repackager's unopened original tamper-evident packaging.

(L) "Prescription drug" has the same meaning as in section 3715.87 of the Revised Code.

(M) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(N) "Underinsured" means any of the following:

(1) Having health care coverage or prescription drug coverage but having exhausted these benefits or being unable to afford any associated deductible, coinsurance, copayments, or similar charges for the drug prescribed; or

(2) Not having prescription drug coverage for the drug prescribed.

Last updated December 2, 2024 at 1:41 PM

History

Effective: May 27, 2023
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-10-02 Eligibility requirements for a pharmacy, hospital, or nonprofit.

A pharmacy, hospital, or nonprofit clinic may elect to participate in a drug repository program, pursuant to sections 3715.87 to 3715.873 of the Revised Code, if all of the following requirements are met:

(A) Must be licensed as a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code.

(B) Must comply with all applicable federal and state laws, rules, and regulations.

(C) A pharmacy, hospital, or nonprofit clinic that operates a drug repository program that receives donations or dispenses medications to the general public shall notify the board, in a manner determined by the board, within thirty days of establishing a repository program.

(D) A pharmacy, hospital, or nonprofit clinic that no longer operates a drug repository program that receives donations or dispenses medications to the general public shall notify the board, in a manner determined by the board, within thirty days of discontinuation.

Last updated December 2, 2024 at 1:41 PM

History

Effective: May 27, 2023
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-10-03 Donating drugs.

(A) The following may donate or facilitate the donation of a drug, pursuant to the eligibility requirements of rule 4729:5-10-04 of the Administrative Code, to a pharmacy, hospital, or nonprofit clinic that elects to participate in a drug repository program:

(1) Any pharmacy, drug manufacturer, or health care facility, or other person or government entity may donate or give drugs to a drug repository program.

(2) Any person or government entity may facilitate the donation or gift of drugs to the program.

(B) Except as provided in paragraph (C) of this rule, a person electing to donate an eligible dangerous drug shall not have taken custody of the drug prior to the donation. The person may direct the donation through any entity or person authorized in paragraph (A) of this rule.

(1) Orally administered cancer drugs described in paragraph (B) of rule 4729:5-10-04 of the Administrative Code;

(2) Drugs described in paragraph (C) of rule 4729:5-10-04 of the Administrative Code donated to a charitable pharmacy, hospital, or nonprofit clinic.

(D) A person who resides in an institutional facility and was legally dispensed a dangerous drug pursuant to a patient-specific order may elect to sign and date a donor form prior to donating a drug, which shall state "from this day forward I wish to donate all my remaining unused drugs that are eligible, pursuant to rule 4729:5-10-04 of the Administrative Code, to a drug repository program."

(E) The following may make the decision to donate an eligible drug on behalf of a patient:

(1) A person designated by durable power of attorney, a guardian, or other individual responsible for the care and well-being of a patient; or

(2) An executor, administrator, or trustee of the estate of a deceased patient.

Last updated December 2, 2024 at 1:41 PM

History

Effective: May 27, 2023
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-10-04 Eligible drugs and storage requirements.

(A) Except as provided in paragraphs (B) and (C) of this rule, drugs donated to a repository program shall be in the original sealed and tamper-evident unit dose packaging and shall meet all of the following requirements:

(1) The packaging shall be unopened except that the drugs packaged in single unit doses may be accepted and dispensed when the outside packaging is opened if the single unit dose packaging is undisturbed.

(2) If the drugs were packaged by a pharmacy, the name of the pharmacy and any other pharmacy identifiers shall be removed from the packaging prior to dispensing or personally furnishing to a recipient patient. This may be accomplished by removing the drug from the pharmacy packaging or by removing the name from the outside packaging of a multiple dose, unit dose packaging system.

(3) The drugs have not been in the possession of the patient and are under the control of the pharmacy, drug manufacturer, government entity, or health care facility.

(4) The drugs have been stored according to federal and state requirements.

(5) The drugs shall include an expiration date on the label or packaging. If the prescription container is the manufacturer's original sealed packaging, the expiration date is the expiration date listed on the packaging. A repository program shall not dispense or personally furnish a donated drug that is beyond the expiration date.

(6) The repository program shall develop and implement standards and procedures to determine, based on a basic visual inspection by a licensed pharmacist or prescriber, that the drugs appear to be unadulterated, safe, and suitable for dispensing or personally furnishing.

(7) The drugs shall not have any physical signs of tampering, misbranding, or adulteration.

(8) The drug packaging shall not have any physical signs of tampering.

(9) Pursuant to division (J) of section 3715.873 of the Revised Code the following drugs and drug types are prohibited from being donated to a repository program in accordance with this paragraph, as they are prohibited from donation by federal or state law or may pose a significant health risk to employees or patients of a repository program:

(a) Controlled substances, except for controlled substances in a long-acting or extended-release form used for the treatment of opioid dependence or addiction.

(b) Drug samples, unless the repository is operated by a charitable pharmacy.

(d) A drug for which the United States food and drug administration requires, as a risk evaluation and mitigation strategy, that the patient be registered with the drug's manufacturer.

(e) Compounded drugs.

(B) A drug repository program operated by a pharmacy, hospital, or non-profit clinic may accept donations of orally administered cancer drugs, as defined in rule 4729:5-10-01 of the Administrative Code, that are not in the original sealed and tamper-evident unit dose packaging if all of the following requirements are met:

(1) The repository program shall develop and implement standards and procedures to determine, based on a basic visual inspection by a licensed pharmacist or prescriber, that the drugs appear to be unadulterated, safe, and suitable for dispensing or personally furnishing.

(2) The drugs have been stored according to federal and state requirements.

(3) The drugs shall include an expiration date on the label or packaging. If the prescription container is the manufacturer's original sealed packaging, the expiration date is the expiration date listed on the packaging. A repository program shall not dispense or personally furnish a donated drug that is beyond the expiration date.

(4) The drugs shall not have any physical signs of tampering, misbranding, or adulteration.

(5) The drugs do not require refrigeration, freezing, or storage at a special temperature.

(6) Pursuant to division (J) of section 3715.873 of the Revised Code the following drugs and drug types are prohibited from being donated to a repository program in accordance with this paragraph, as they are prohibited from donation by federal or state law or may pose a significant health risk to employees or patients of a repository program:

(a) Controlled substances.

(b) Drug samples, unless the repository is operated by a charitable pharmacy.

(d) A drug for which the United States food and drug administration requires, as a risk evaluation and mitigation strategy, that the patient be registered with the drug's manufacturer.

(e) Compounded drugs.

(7) Nothing in this paragraph prohibits a drug repository program operated by a pharmacy, hospital, or non-profit clinic from accepting donations of orally administered cancer drugs that are in the original sealed and tamper-evident unit dose packaging if the program complies with the requirements of this paragraph.

(C) A drug repository program operated by a charitable pharmacy, hospital, or non-profit clinic may accept donations of drugs, including any such drugs that are orally administered cancer drugs or that may require storage at a special temperature, that are not in the original sealed and tamper-evident unit dose packaging if all of the following requirements are met:

(2) The drugs have been stored according to federal and state requirements.

(4) The drugs shall not have any physical signs of tampering, misbranding, or adulteration.

(5) Pursuant to division (J) of section 3715.873 of the Revised Code the following drugs and drug types are prohibited from being donated to a repository program in accordance with this paragraph, as they are prohibited from donation by federal or state law or may pose a significant health risk to employees or patients of a repository program:

(a) Controlled substances.

(b) Drug samples, unless the repository is operated by a charitable pharmacy.

(d) A drug for which the United States food and drug administration requires, as a risk evaluation and mitigation strategy, that the patient be registered with the drug's manufacturer.

(e) Compounded drugs.

(6) Nothing in this paragraph prohibits a drug repository program operated by a pharmacy, hospital, or non-profit clinic from accepting donations of drugs that are in the original sealed and tamper-evident unit dose packaging if the program complies with the requirements of this paragraph.

(D) In the case of recalls, any donated drugs affected by the recall shall not be dispensed or personally furnished unless the lot number can be determined.

(E) A repository shall quarantine the donated drugs separately from all dispensing stock until the donated drugs have been inspected and approved in accordance with this rule.

(F) No drugs may be dispensed or personally furnished by a drug repository that contain any confidential patient information from the original donor.

Last updated May 30, 2023 at 8:27 AM

History

Effective: May 27, 2023
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-10-05 Eligibility requirements to receive drugs.

A pharmacy, hospital, or nonprofit clinic that elects to participate in a drug repository program must determine if a person is eligible to receive drugs. A person must meet the following requirements to become an eligible recipient of drugs from a drug repository program:

(A) Is a resident of Ohio or currently resides in this state; and

(B) Meets any of the following criteria:

(1) Is uninsured or underinsured as defined in rule 4729:5-10-01 of the Administrative Code; or

(2) Meets any other eligibility requirements, as determined by the repository program's eligibility policy.

Last updated December 2, 2024 at 1:41 PM

History

Effective: May 27, 2023
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-10-06 Donor and recipient forms.

(A) Each donor must sign an electronic or physical form stating that the donor is the owner of the drug and intends to voluntarily donate the drug to the drug repository program. The donor form must be completed prior to any donation and include at least the following:

(1) The name of the person that was originally dispensed the drugs or the name of the entity that owns the drugs.

(2) The full name, contact phone, and signature of the donor, which may include any of the following:

(a) The person designated by durable power of attorney, a guardian, an individual responsible for the care and well-being of a patient;

(b) The executor, administrator, or trustee of the estate of a deceased patient;

(c) The responsible person or the responsible person's designee of a terminal distributor of dangerous drugs or a drug distributor;

(d) The licensed prescriber or pharmacist responsible for the oversight of the entity donating the drug.

(3) The address of the donor or the entity donating the drug.

(4) The date the form was signed.

(B) The following donor information must also be documented. This information may be documented on the original signed donor form or on an alternate record created by the repository program. If an alternate record is used, the record must include the name of the donor in addition to the required information in this paragraph.

(1) The brand name or generic name of the drug donated and either the name of the manufacturer or the national drug code number (NDC#).

(2) The strength of the drug donated.

(3) The quantity of the drug donated.

(4) The date the drug was donated.

(C) Prior to receiving donated drugs from a drug repository program, each recipient must sign an electronic or physical form stating they understand the immunity provisions of the program pursuant to division (B) of section 3715.872 of the Revised Code.

(D) Donor forms shall be maintained for a minimum of three years in a readily retrievable manner by the repository program.

(E) Recipient forms shall be maintained for a minimum of three years in a readily retrievable manner by the repository program.

(F) A prescriber shall document the distribution of a personally furnished donated repository program drug to the prescriber's patient pursuant to the applicable record keeping rules of division 4729:5 of the Administrative Code and a pharmacy shall document the dispensing of a donated repository program drug pursuant to the applicable record keeping rules of division 4729:5 of the Administrative Code. Such records shall indicate that the drug distributed to a patient was from a repository program. If recipient forms are used with each dispensing or personal furnishing, this information may be documented on the recipient form.

Last updated December 2, 2024 at 1:41 PM

History

Effective: May 27, 2023
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-10-07 Occasional sales and handling fee.

(A) A pharmacy, hospital, or nonprofit clinic may charge the recipient of a donated drug a handling fee up to twenty dollars to cover restocking and dispensing costs. If a drug repository program chooses to charge a handling fee, then the fees collected in any given year shall not exceed the program's total restocking and dispensing costs for that given year.

(B) A charitable pharmacy, hospital, or nonprofit clinic that operates a drug repository program may conduct occasional sales at wholesale of drugs that have been donated or given to the program if all of the following apply:

(1) The receiving location is a charitable pharmacy, hospital, or nonprofit clinic that operates a drug repository program in this state or an entity participating in a drug repository program operated by another state subject to the laws of that state.

(2) The seller maintains a record of or sale that contains the following information:

(a) The name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, the date of transfer or sale; or

(b) In lieu of the requirements listed in paragraph (B)(2)(a) of this rule, a hospital may document the transfer of the drug within the hospital system in accordance with paragraph (F) of rule 4729:5-9-02.3 of the Administrative Code.

(3) The seller provides a copy of the record of sale as outlined in this paragraph to the receiver.

(4) The seller and receiver maintain a record of the sale for three years from the date of creation in a readily retrievable manner.

Last updated May 30, 2023 at 8:28 AM

History

Effective: May 27, 2023
Promulgated Under: 119.03

Chapter 4729:5-11 Pain Management Clinics

Ohio Adm.Code 4729:5-11-01 Pain management clinics - definitions.

As used in Chapter 4729:5-11 of the Administrative Code:

(A) "Pain management clinic" means a facility licensed as a terminal distributor of dangerous drugs in accordance with section 4729.552 of the Revised Code. The facility shall comply with all requirements set forth in this chapter.

(B) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(D) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as in rule 4729:5-1-02 of the Administrative Code but shall be limited to a prescriber practicing within the prescriber's applicable scope of practice.

(E) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(F) "Personally furnish" or "personally furnishing" means the final association of a drug with a patient by a prescriber prior to the distribution to a patient for use outside the prescriber's practice setting. A prescriber at a pain management clinic who personally furnishes a dangerous drug shall comply with the requirements of rule 4729:5-19-02 of the Administrative Code.

(G)

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier.

(H) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer, or inspector of the board.

(I) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

Last updated April 1, 2026 at 8:31 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-11-02 Criminal records checks for pain management clinics.

(A) As used in this rule, "physician" means a person authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery.

(B) All criminal records checks conducted in accordance with this rule shall consist of both an Ohio bureau of criminal identification (BCI) records check and a federal bureau of investigations (FBI) records check.

(C) Pursuant to section 4729.552 of the Revised Code, a terminal distributor of dangerous drug license with a pain management clinic classification will not be issued until the physician owner(s) or, if incorporated, the physician officers of the pain management clinic submit fingerprints to BCI for a criminal records check, which shall also include an FBI records check. The results of the criminal records check must be sent directly to the state board of pharmacy from BCI. To be considered valid, the criminal records check must have been performed within the past twelve months.

(D) If there is a change in any of the persons listed in paragraph (C) of this rule, only the new persons shall submit to a criminal records check as part of the change of ownership requirements pursuant to rule 4729:5-2-03 of the Administrative Code.

(E) Physician owner(s) or physician officers are required to have all employees submit to a BCI and FBI criminal records check to ensure that no person has been previously convicted of, or pleaded guilty to, a theft offense that would constitute a felony as described in division (K)(3) of section 2913.01 of the Revised Code or a felony drug abuse offense as defined in section 2925.01 of the Revised Code.

(1) BCI shall send the results of the BCI criminal records check directly to the employer or potential employer. BCI shall provide a letter regarding the FBI criminal records check to the employer or potential employer stating that there is either no record of any conviction or a letter stating that the request may not meet the criteria.

(2) When an employer or potential employer receives a letter stating that the request may not meet the criteria, they may share this information with the employee or potential employee.

(3) In order to complete the criminal records check, the employee or potential employee must then complete a "Request for Release-FBI Rapsheet" and send it to BCI to request a copy of the FBI criminal records check results be sent directly to the employee or potential employee. The employee or potential employee must provide the results to the employer or potential employer in the original sealed envelope received from BCI.

(4) The criminal records check shall be based on electronic fingerprint impressions that are submitted directly to BCI from a WebCheck provider agency located in Ohio. The employer may accept the results of a criminal records check based on ink impressions from a WebCheck provider agency only in the event that readable electronic fingerprint impressions cannot be obtained.

Last updated April 1, 2026 at 8:31 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-11-03 Security, control and storage of dangerous drugs.

(A) The security and control of dangerous drugs is the responsibility of the responsible person on the terminal distributor of dangerous drugs license and the terminal distributor of dangerous drugs.

(B) Except as provided in paragraphs (F) and (G) of this rule, controlled substance dangerous drugs shall be stored in a securely locked, substantially constructed cabinet or safe to deter and detect unauthorized access.

(1) The cabinet or safe shall be placed in an area that is not readily accessible to the public.

(2) The cabinet or safe shall remain locked and secured when not in use.

(3) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(4) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a prescriber or pharmacist if not being used by a prescriber, pharmacist or a licensed health care professional in accordance with paragraph (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule. All locks shall be kept in good working order with keys removed therefrom.

(5) During non-business hours, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(6) Except as provided in paragraph (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule, only a prescriber or pharmacist shall be able to access the cabinet or safe.

(a) A prescriber or pharmacist may provide a licensed health care professional with a temporary key for the purposes of accessing the cabinet or safe. A licensed health care professional shall return the key provided in accordance with this paragraph to the prescriber or pharmacist or to a secured location with restricted access (such as a lockbox) no later than the end of the provider's shift or if there is no longer a prescriber or pharmacist available to provide personal supervision.

(b) A prescriber or pharmacist may provide a licensed health care professional with a key, combination, or access code for the purposes of accessing the cabinet or safe, if all the following conditions apply:

(i) The cabinet or safe is maintained in a room secured by a physical barrier with suitable locks that can only be unlocked by a prescriber or pharmacist; and

(ii) The room is locked during non-business hours or when there is no longer a prescriber or pharmacist available to provide personal supervision.

(c) Any other method approved by the board's executive director or the director's designee that provides effective controls and procedures to guard against theft and diversion.

(C) Except as provided in paragraph (G) of this rule, a licensed health care professional, acting within the scope of the professional's practice, may have access to controlled substances only under the personal supervision of a prescriber or pharmacist.

(D) Only a prescriber shall have access to uncompleted prescription blanks used for writing a prescription. Uncompleted prescription blanks shall be secured when not in use.

(E) Personnel authorized by the responsible person may have access to D.E.A. controlled substance order forms only under the personal supervision of a prescriber or a person delegated power of attorney in accordance with 21 CFR 1305.05 (9/30/2019). D.E.A. controlled substance order forms shall be secured when not in use.

(F) Thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine shall be stored in a separate safe or steel cabinet equivalent to a U.S. government class V security container from all other controlled substances.

(1) There is no minimum size or weight requirement but if the cabinet or safe weighs less than seven hundred fifty pounds, it must be secured to the floor or wall in such a way that it cannot be readily removed.

(2) The cabinet or safe shall be placed in an area that is not readily accessible to the public. During non-business hours, the cabinet or safe shall be stored in an area secured by a physical barrier with suitable locks, which may include a locked room or secured facility.

(3) The cabinet or safe shall remain locked and secured when not in use.

(4) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access codes.

(5) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a prescriber or pharmacist if not being used by a prescriber or pharmacist. All locks shall be kept in good working order with keys removed therefrom.

(6) During non-business hours, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(7) Only a prescriber or pharmacist shall be able to access the safe or cabinet.

(G) A nurse licensed under Chapter 4723. of the Revised Code may have unsupervised access to controlled substances only under the following conditions:

(1) The drugs have been personally furnished by a prescriber or dispensed by a pharmacy for direct administration to a patient.

(2) The drugs must be stored in a securely locked, substantially constructed cabinet or safe with access that is limited to prescribers, pharmacists, and nurses. The cabinet or safe must be separate from those required in paragraphs (B) and (F) of this rule.

(a) The cabinet or safe shall be placed in an area that is not readily accessible to the public.

(b) The cabinet or safe shall remain locked and secured when not in use.

(c) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(d) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a prescriber, pharmacist or nurse.

(e) During non-business hours, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(3) A record of drug administration shall be maintained in accordance with paragraph (E) of rule 4729:5-11-04 of the Administrative Code and shall also include the date and time the drugs are accessed from the cabinet or safe.

(4) The responsible person shall report the theft or significant loss of drugs maintained pursuant to this paragraph in accordance with rule 4729:5-3-02 of the Administrative Code.

(H) During non-business hours, hypodermics shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, locked room, or secured facility. During normal business hours, hypodermics shall not be stored in areas where members of the public are not supervised by individuals authorized to administer injections.

(I) During non-business hours, non-controlled dangerous drugs shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, locked room, or secured facility. During normal business hours, non-controlled dangerous drugs shall not be stored in areas where members of the public are not supervised by individuals authorized to administer such drugs.

(J) All records relating to the receipt, administration, distribution, personal furnishing, and sale of dangerous drugs shall be maintained under appropriate supervision and control to restrict unauthorized access.

(K) All areas where dangerous drugs are stored shall be dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the drugs prior to use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Refrigerators and freezers used for the storage of drugs shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs.

(M) Adulterated drugs, including expired drugs, shall be stored in accordance with rule 4729:5-3-06 of the Administrative Code.

(N) Disposal of controlled substances shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code.

(O) Disposal of non-controlled dangerous drugs shall be conducted in accordance with rule 4729:5-3-06 of the Administrative Code.

Last updated April 1, 2026 at 8:31 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-11-04 Record keeping.

(A) A pain management clinic shall keep a record of all dangerous drugs received, administered, personally furnished, disposed, sold, or transferred.

(B) Records of receipt shall contain the name, strength, dosage form, and quantity of the dangerous drugs received, the name and address of the seller, the name and address of the recipient, and the date of receipt. An invoice from a drug distributor licensed in accordance with division 4729:6 of the Administrative Code containing the required information may be used to meet this requirement.

(C) Records of temperature control monitoring described in paragraph (K)(1) of rule 4729:5-11-03 of the Administrative Code shall include any of the following:

(1) For temperature logs, either:

(a) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(b) For systems that provide automated temperature monitoring, maintain a report that provides, at a minimum, the date and time of observation and the temperature recorded.

(D) Records of personally furnishing shall contain the name, strength, dosage form, and quantity of the dangerous drugs personally furnished; the name, address and date of birth of the person to whom or for whose use the dangerous drugs were personally furnished; the positive identification of the prescriber personally furnishing the drug; the date the drug is personally furnished; and, if applicable, the date the drug is received by the patient or patient's caregiver.

(E)

(1) Records of administration shall contain the name, strength, dosage form, and quantity of the dangerous drugs administered; the name and date of birth of the person to whom or for whose use the dangerous drugs were administered; the date of administration; and either:

(a) For non-controlled substance dangerous drugs: the identification of the health care professional administering the drug.

(b) For controlled substance dangerous drugs: the positive identification of the health care professional administering the drug.

(2) Records of dangerous drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(3) Records of dangerous drugs administered by a health care professional, acting within the professional's scope of practice, who is not a prescriber shall include documentation of an order issued by a prescriber or protocol authorizing the administration of the drug. An order that is a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph. Orders for the administration of controlled substances shall be documented using positive identification.

(4) Paragraph (E)(3) of this rule does not apply to the administration of dangerous drugs pursuant to paragraph (G) of rule 4729:5-11-03 of the Administrative Code or non-controlled dangerous drugs for direct administration to a patient that have been dispensed by a pharmacy or personally furnished by a prescriber.

(F) Records of disposal of dangerous drugs from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed; the date of disposal; the method of disposal; and the identification of the licensed health care professional that performed the disposal.

(G) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory is performed on-site, records shall also include the positive identification of two licensed health care professionals conducting and witnessing the disposal, one of whom shall be the responsible person or the responsible person's designee.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient, records shall also include the positive identification of two licensed health care professionals conducting and witnessing the disposal.

(H) Records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code shall contain the name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(I) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

(J) All records maintained in accordance with this rule shall be readily retrievable and shall be kept on-site for a period of three years.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(K) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) Complies with the requirements of this rule;

(2) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features, such as unique user names and passwords, to prevent unauthorized access; and

(4) Contains daily back-up functionality to protect against record loss.

Last updated April 1, 2026 at 8:32 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Chapter 4729:5-12 Medication Therapy Management

Ohio Adm.Code 4729:5-12-01 Medication therapy management - definitions.

As used in in Chapter 4729:5-12 of the Administrative Code:

(A) "Personal supervision" or "direct supervision" means a pharmacist shall be physically present in the pharmacy, or in the area where the practice of pharmacy is occurring, and provide personal review and approval of all professional activities.

(B) "Medication therapy management" or "MTM" means:

(1) A distinct service or group of services that is intended to optimize the therapeutic outcomes of a patient. Medication therapy management can be an independent service provided by a pharmacist or pharmacy intern under the direct supervision of a pharmacist or can be in conjunction with the dispensing of a dangerous drug with the objectives of:

(a) Enhancing appropriate medication use;

(b) Improving medication adherence;

(d) Improving collaboration between a prescriber and pharmacist; and

(e) Improving outcomes.

(2) Medication therapy management may only be performed by the following:

(a) An Ohio licensed pharmacist;

(b) An Ohio licensed pharmacy intern practicing in this state under the direct supervision of a pharmacist; and

(C) "Limited category II terminal distributor of dangerous drugs license with a medication therapy management classification" means a limited category II terminal distributor of dangerous drugs license issued by the state board of pharmacy in accordance with section 4729.54 of the Revised Code to a person solely engaged in the practice of medication therapy management.

A limited category II terminal distributor of dangerous drugs license with a medication therapy management classification does not entitle the holder to possess or sell dangerous drugs.

(D) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that they can be separated out from all other records and produced for review by an agent of the board within three business days.

(E) "State" means a state of the United States, the District of Columbia, the Commonwealth of Puerto Rico, or a territory or insular possession subject to the jurisdiction of the United States.

Last updated July 1, 2024 at 5:30 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-12-02 Medication therapy management.

(A) A pharmacist or pharmacy intern under the direct supervision of a pharmacist who provides medication therapy management services shall practice at a location that complies with one of the following:

(1) If the person or entity solely performs medication therapy management in this state or to residents of this state, the location shall be licensed as a limited category II terminal distributor of dangerous drugs license with a medication therapy management classification; or

(2) If the person or entity engages in the sale of dangerous drugs, the location is appropriately licensed as a terminal distributor of dangerous drugs.

(B) A non-resident provider of medication therapy management shall obtain the appropriate licensure in accordance with paragraph (A) of this rule.

(C) The number of interns engaged in the practice of medication therapy management at any time is limited to not more than two for each pharmacist on duty unless otherwise approved by the board.

(D) A pharmacist or pharmacy intern under the direct supervision of a pharmacist that provides medication therapy management services shall ensure that they are provided according to the individual needs of a patient and may include the following:

(1) Performing or otherwise obtaining a patient's health status assessment;

(2) Developing a medication treatment plan for monitoring and evaluating a patient's response to therapy;

(3) Monitoring the safety and effectiveness of the medication therapy;

(4) Performing a medication review to identify, prevent, or resolve medication related problems;

(5) Providing education and training to a patient or a patient's agent on the use or administration of the medication;

(6) Documenting the delivery of care, communications with other involved healthcare providers, and other appropriate documentation and records pursuant to paragraph (E) of this rule;

(7) Providing necessary services to enhance a patient's adherence with the therapeutic regimen;

(8) Integrating medication therapy management services within the overall health management plan for a patient;

(9) Providing for the safe custody and security of all records and compliance with all applicable federal and state laws, rules, and regulations concerning the security and privacy of patient information; and

(10) Any other activity as determined by the board.

(E) All records relating to medication therapy management service shall:

(1) Provide accountability and an audit trail; and

(2) Be uniformly maintained for a period of three years and shall be made readily retrievable.

Last updated July 1, 2024 at 5:30 PM

History

Effective: July 1, 2024
Promulgated Under: 119.03

Chapter 4729:5-13 First Aid Departments

Ohio Adm.Code 4729:5-13-01 First aid departments - definitions.

As used in Chapter 4729:5-13 of the Administrative Code:

(A) "First aid department" means a facility licensed as a limited terminal distributor of dangerous drugs in accordance with section 4729.54 of the Revised Code that stocks or administers dangerous drugs in conjunction with the treatment of medical emergencies. The facility shall comply with all requirements set forth in this chapter.

(B) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(E) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(F) "Personally furnish" or "personally furnishing" means the final association of a drug with a patient by a prescriber prior to the distribution to a patient for use outside the prescriber's practice setting. A prescriber at a first aid department who personally furnishes a dangerous drug shall comply with the requirements of rule 4729:5-19-02 of the Administrative Code.

(G)

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier.

Last updated April 1, 2026 at 8:32 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-13-02 Licensure and drug list.

(A) An application for licensure shall include all the following:

(1) A completed application;

(2) A list of the dangerous drugs, known as a drug list, that may be possessed and administered or personally furnished by a first aid department, expressed in standard dose units, signed by the responsible person; and

(3) The fee for the appropriate category of licensure.

(B) A first aid department may only possess those dangerous drugs that are on the drug list submitted to the board pursuant to paragraph (A)(2) of this rule and only at locations licensed by the state board of pharmacy. The responsible person may modify the drugs that may be possessed and administered by a first aid department by submitting a new drug list to the state board of pharmacy in a manner determined by the board.

(C) Except as authorized pursuant to rule 4729:5-3-09 of the Administrative Code, a first-aid department that purchases dangerous drugs for first-aid departments in other locations and redistributes them shall obtain a license as a wholesale distributor of dangerous drugs.

Last updated August 14, 2025 at 10:11 AM

History

Effective: March 1, 2020
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-13-03 Security, control and storage of dangerous drugs.

(A) The security and control of dangerous drugs is the responsibility of the responsible person on the terminal distributor of dangerous drugs license and the terminal distributor of dangerous drugs.

(1) The cabinet or safe shall be placed in an area that is not readily accessible to the public.

(2) The cabinet or safe shall remain locked and secured when not in use.

(3) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(4) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a prescriber or pharmacist if not being used by a prescriber, pharmacist, or a licensed health care professional in accordance with paragraph (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule. All locks shall be kept in good working order with keys removed therefrom.

(5) During non-business hours, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(6) Except as provided in paragraph (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule, only a prescriber or pharmacist shall be able to access the cabinet or safe.

(b) A prescriber or pharmacist may provide a licensed health care professional with a key, combination or access code for the purposes of accessing the cabinet or safe, if all the following conditions apply:

(i) The cabinet or safe is maintained in a room secured by a physical barrier with suitable locks that can only be unlocked by a prescriber or pharmacist; and

(ii) The room is locked during non-business hours or when there is no longer a prescriber or pharmacist available to provide personal supervision.

(c) Any other method approved by the board's executive director or the director's designee that provides effective controls and procedures to guard against theft and diversion.

(D) Only a prescriber shall have access to uncompleted prescription blanks used for writing a prescription. Uncompleted prescription blanks shall be secured when not in use.

(2) The cabinet or safe shall be placed in an area that is not readily accessible to the public.

(3) The cabinet or safe shall remain locked and secured when not in use.

(6) During non-business hours, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(7) Only a prescriber or pharmacist shall be able to access the safe or cabinet.

(G) A nurse licensed under Chapter 4723. of the Revised Code, may have unsupervised access to controlled substances only under the following conditions:

(1) The drugs have been personally furnished by a prescriber or dispensed by a pharmacy for direct administration to a patient.

(a) The cabinet or safe shall be placed in an area that is not readily accessible to the public.

(b) The cabinet or safe shall remain locked and secured when not in use.

(c) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(d) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a prescriber, pharmacist, or nurse.

(e) During non-business hours, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(3) A record of drug administration shall be maintained in accordance with paragraph (E) of rule 4729:5-13-04 of the Administrative Code and shall also include the date and time the drugs are accessed from the cabinet or safe.

(4) The responsible person shall report the theft or significant loss of drugs maintained pursuant to this paragraph in accordance with rule 4729:5-3-02 of the Administrative Code.

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs.

(M) Dangerous drugs shall only be administered by a licensed health care professional, acting within the scope of the professional's practice, in accordance with a prescriber's order or protocols authorized by a prescriber pursuant to rule 4729:5-3-12 of the Administrative Code. A copy of the protocols shall be maintained on-site for immediate inspection by an agent, officer, or inspector of the board.

(N) Adulterated drugs, including expired drugs, shall be stored in accordance with rule 4729:5-3-06 of the Administrative Code.

(O) Disposal of controlled substances shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code.

(P) Disposal of non-controlled dangerous drugs shall be conducted in accordance with rule 4729:5-3-06 of the Administrative Code.

Last updated April 1, 2026 at 8:32 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-13-04 Record keeping.

(A) A first aid department shall keep a record of all dangerous drugs received, administered, personally furnished, disposed, sold, or transferred.

(C) Records of temperature control monitoring described in paragraph (K)(1) of rule 4729:5-13-03 of the Administrative Code shall include any of the following:

(1) For temperature logs, either:

(a) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(b) For systems that provide automated temperature monitoring, maintain a report that provides, at a minimum, the date and time of observation and the temperature recorded.

(E)

(a) For non-controlled substance dangerous drugs: the identification of the health care professional administering the drug.

(b) For controlled substance dangerous drugs: the positive identification of the health care professional administering the drug.

(2) Records of dangerous drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(4) Paragraph (E)(3) of this rule does not apply to the administration of dangerous drugs pursuant to paragraph (G) of rule 4729:5-13-03 of the Administrative Code or non-controlled dangerous drugs for direct administration to a patient that have been dispensed by a pharmacy or personally furnished by a prescriber.

(G) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory is performed on-site, records shall also include the positive identification of two licensed health care professionals conducting and witnessing the disposal, one of whom shall be the responsible person or the responsible person's designee.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient, records shall also include the positive identification of two licensed health care professionals conducting and witnessing the disposal.

(I) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

(J) All records maintained in accordance with this rule shall be readily retrievable and shall be kept on-site for a period of three years.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(1) Complies with the requirements of this rule;

(2) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features, such as unique user names and passwords, to prevent unauthorized access; and

(4) Contains daily back-up functionality to protect against record loss.

(L) All purchase orders or requisitions for dangerous drugs must be signed by the first aid department's responsible person.

Last updated April 1, 2026 at 8:33 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Chapter 4729:5-14 Emergency Medical Services

Ohio Adm.Code 4729:5-14-01 Emergency medical services - definitions.

As used in Chapter 4729:5-14 of the Administrative Code:

(A) "Business day" means any day other than Saturday, Sunday or a holiday recognized by the state of Ohio on which the offices of the board of pharmacy are not open for business.

(B) "Certificate to practice" means the certificate to practice as an emergency medical responder, emergency medical technician, advanced emergency medical technician, or paramedic issued by the division of emergency medical services within the department of public safety pursuant to section 4765.30 of the Revised Code and Chapter 4765-8 of the Administrative Code.

(C) "Direct supervision" or "personal supervision" means EMS organization personnel shall be physically present at the licensed location or within the immediate proximity of an EMS unit to deter and detect the diversion of dangerous drugs.

(D) "Electronic signature" means any of the following attached to or associated with an electronic drug administration record by EMS organization personnel to authenticate the drug administration record:

(1) A private, unique personal identifier and secure passcode consisting of a combination of letters, numbers, and symbols that is adapted or executed by an individual as that individual's electronic signature.

(2) An electronic image of an individual's handwritten signature that is captured following drug administration and is created by using a writing apparatus (i.e. stylus). The signature shall be legible and include the person's first name, last name and credentials.

(3) Any other method approved by the board.

(E) "Emergency medical service organization" or "EMS organization" has the same meaning as in section 4765.01 of the Revised Code.

(F) "Medical director" means a physician to whom an EMS organization has designated, pursuant to section 4765.42 of the Revised Code, to perform the duties of medical director including establishing medical protocols that must be followed in the delivery of emergency medical services.

The program medical director shall be registered with the United States drug enforcement administration pursuant to 21 U.S.C. 823 (December 7, 2023).

(G) "Mutual aid" means a formal written agreement between two or more EMS organizations to assist in emergency medical coverage in the other's usual area of coverage, including having access to dangerous drugs during the emergency.

(H)

(1) "Positive identification" means a method of identifying EMS personnel that does not rely solely on the use of a private personal identifier such as a password, but must also include a secure means of identification such as the following:

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier.

(I) "Protocol" or "standing order" means a definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized and signed by the EMS organization's medical director. A protocol may be used only by licensed or certified EMS personnel or individuals licensed in accordance with Chapter 4723. of the Revised Code, in accordance with the individual's scope of practice, when providing limited medical services to individuals in an emergency.

(J) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that they can be separated out from all other records and, upon request, produced for review no later than three business days to an agent, officer or inspector of the board.

(K) "Responsible person" has the same meaning as defined in agency 4729 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and maintaining all drug records otherwise required.

(L) "Satellite" means a location licensed by the state board of pharmacy as a terminal distributor of dangerous drugs that is separate from the licensed headquarters of the EMS organization.

(M) "Scope of practice" has the same meaning as defined as in section 4765.35 of the Revised Code and Chapter 4765-12 of the Administrative Code for an emergency medical responder or first responder, section 4765.37 of the Revised Code and Chapter 4765-15 of the Administrative Code for an emergency medical technician or emergency medical technician-basic, section 4765.38 of the Revised Code and Chapter 4765-16 of the Administrative Code for an advanced emergency medical technician or emergency medical technician-intermediate, and section 4765.39 of the Revised Code and Chapter 4765-17 of the Administrative Code for a paramedic or emergency medical technician-paramedic.

(N) "Tamper-evident" means a package, storage container, or other physical barrier that is sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

(O) "Verbal order" means an oral directive that is given through any method of communication including by radio or telephone, directly to an emergency medical services professional, to contemporaneously administer a dangerous drug, including a controlled substance, to individuals in need of emergency medical services outside the physical presence of the medical director or authorizing medical professional.

Last updated December 4, 2025 at 2:30 PM

History

Effective: December 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-14-02 Licensure.

(A) An EMS organization that possesses dangerous drugs shall apply for and maintain a license as a terminal distributor of dangerous drugs with an emergency medical services classification.

(1) The location that serves as the main station of the EMS organization will be deemed the headquarters. The headquarters shall be the location where records and drugs for distribution to satellite locations are maintained.

(2) Any satellite location associated with the headquarters of the EMS organization where dangerous drugs will be stored must be licensed as a terminal distributor of dangerous drugs.

(B) An application for licensure shall include all the following:

(1) A completed application;

(2) A copy of the organization's protocols signed by the medical director;

(3) A list of the dangerous drugs, or drug list, that may be possessed and administered by EMS organization personnel, expressed in standard dose units, signed by the medical director;

(4) A list of personnel employed, including volunteers, by the EMS organization who may access and administer dangerous drugs, which includes the name of each employee or volunteer, level of certification, certification number, and expiration date; and

(5) The fee for the appropriate category of licensure.

(C) Each location, headquarters and satellite, may only possess those dangerous drugs that are on the drug list submitted to the board pursuant to paragraph (B)(3) of this rule and only at locations licensed by the state board of pharmacy.

(1) A medical director may modify the drugs that may be possessed and administered by EMS organization personnel by submitting a new drug list to the state board of pharmacy in a manner determined by the board.

(2) A modification to the drug list shall require an update to the EMS organization's protocols. Any updates or changes to the protocols shall only be submitted to the board upon request.

(D) If there is a change of the medical director of an EMS organization, the new medical director shall submit notification, in a manner determined by the board, no later than five business days following the change. Notification shall include a current drug list signed by the new medical director.

(E) Any change of the EMS organization's personnel list shall be updated within thirty days of a change of personnel. Any change of personnel shall only be submitted to the board upon request.

(F) An EMS organization shall maintain a current copy or have access to a current copy of the organization's protocols, personnel list and drug list at each licensed location.

Last updated December 4, 2025 at 2:28 PM

History

Effective: December 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-14-03 Security and control of dangerous drugs.

(A) The security and control of dangerous drugs is the responsibility of the responsible person on the terminal distributor of dangerous drugs license. The responsible person may delegate the day-to-day tasks to EMS organization personnel who hold appropriate certification/licensure to access the dangerous drugs for which the personnel are responsible. A responsible person shall comply with the requirements set forth in rule 4729:5-2-01 of the Administrative Code.

(B) A licensed EMS organization shall provide effective controls and procedures to deter and detect the diversion of dangerous drugs.

(1) Except as provided in paragraph (B)(2) of this rule, only the following may have access to controlled substance dangerous drugs maintained by the EMS organization:

(a) A paramedic (emergency medical technician-paramedic) certified in accordance with Chapter 4765. of the Revised Code;

(b) An advanced emergency medical technician (emergency medical technician-intermediate) certified in accordance with Chapter 4765. of the Revised Code; and

(2) An emergency medical technician (emergency medical technician-basic) certified in accordance with Chapter 4765. of the Revised Code may have access to buprenorphine to administer an initial dose pursuant to paragraph (C) of rule 4729:5-14-05 of the Administrative Code. Buprenorphine maintained in accordance with this paragraph shall:

(a) Be physically secured with access limited to persons listed in paragraphs (B)(1) and (B)(2) of this rule.

(b) Stored in a manner that does not permit an emergency medical technician access to other controlled substance dangerous drugs maintained by the EMS organization.

(3) A certified emergency medical responder (emergency medical responder) and emergency medical technician certified in accordance with Chapter 4765. of the Revised Code may have supervised access to controlled substance dangerous drugs as follows:

(a) For the purpose of documenting the disposal of an unused portion of a controlled substance resulting from administration to a patient in accordance with paragraph (K) of this rule and only under the direct supervision of the persons listed in paragraph (B)(1) of this rule.

(b) For the purpose of documenting the disposal of controlled substances in accordance with paragraph (J) of this rule and only under the direct supervision of the persons listed in paragraph (B)(1) of this rule.

(C)

(1) All non-controlled dangerous drugs maintained by the EMS organization shall be maintained under the direct supervision of licensed or certified EMS personnel employed or affiliated with the EMS organization to deter and detect the diversion of dangerous drugs.

(2) If direct supervision is not possible, the licensed location is not currently in use, or the facility is being utilized to hold an event attended by persons other than licensed or certified EMS personnel, all non-controlled dangerous drugs shall be physically secured with access limited to licensed or certified EMS personnel, except for the following if stored in a sealed, tamper-evident manner:

(a) Solutions labeled for irrigation use;

(b) Dextrose solutions;

(d) Lactated ringers;

(e) Sterile water; and

(f) Naloxone hydrochloride or other overdose reversal drug as defined in rule 4729-8-01 of the Administrative Code.

(D) Except as provided in paragraph (B)(2) of this rule, all controlled substance dangerous drugs maintained by the EMS organization shall be physically secured with access limited to persons listed in paragraph (B)(1) of this rule.

(E) All areas where dangerous drugs and devices are stored shall be dry, well-lit well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling unless otherwise directed by the board. Refrigerators and freezers used for the storage of drugs and devices shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out-of-range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs.

(F) Upon the initial puncture of a multiple-dose vial containing a drug, the vial shall be labeled with a beyond-use date or date opened. The beyond-use date for an opened or entered (e.g., needle punctured) multiple-dose container with antimicrobial preservatives is twenty-eight days, unless otherwise specified by the manufacturer. A multiple-dose vial that exceeds its beyond-use date shall be deemed adulterated.

(G) A dangerous drug that is stored improperly, expired, damaged, tampered, or otherwise adulterated shall be separated from active stock to prevent possible administration to patients. Adulterated drugs shall be stored no longer than one year from the date of adulteration or expiration by the EMS organization. Adulterated drugs shall be stored in a manner that prohibits access by unauthorized persons as required by this rule.

(H) A non-controlled dangerous drug that is expired or adulterated shall be disposed of in a manner that renders the drug unavailable and unusable.

(I) Unless the EMS organization is registered with the United States drug enforcement administration (DEA), any controlled substance that is expired or otherwise adulterated shall be returned to the institutional pharmacy or facility that is owned or operated by a hospital acting as the EMS organization's responsible DEA registrant.

(J) Except as provided in paragraph (K) of this rule, the disposal of controlled substances shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code. The disposal of controlled substances shall be conducted by two licensed or certified EMS personnel, one of whom shall meet the qualifications listed in paragraph (B)(1) of this rule.

(K) The unused portion of a controlled substance resulting from administration to a patient from a licensee's stock or emergency supply may be destroyed using an on-site method. The on-site method does not have to meet the definition of non-retrievable in rule 4729:5-3-01 of the Administrative Code but must render the drug unavailable and unusable.

The destruction of partially used controlled substances shall be conducted by two licensed or certified EMS personnel, one of whom shall meet the qualifications listed in paragraph (B)(1) of this rule.

(L) If there is a recall of oxygen by the manufacturer, all portable oxygen tanks affected by the recall shall be handled in accordance with the manufacturer's recall instructions.

Last updated December 4, 2025 at 2:30 PM

History

Effective: December 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-14-04 Record keeping.

(A) All EMS organizations shall keep a record of all dangerous drugs received, administered, sold, transferred, destroyed, or disposed.

(C) All records of receipt, distribution, administration, selling, disposing, destroying or using dangerous drugs shall be maintained for a period of three years at the place where the dangerous drugs are located.

Records from satellites may be stored at the EMS organization headquarters if prior approval, in a manner determined by the board, is obtained by the EMS organization.

(D) Records of administering dangerous drugs shall be legible and shall contain the first and last name of the EMS personnel who administered the drug, name of the EMS organization, name and strength of the drug administered, date of administration, time of administration, amount of the drug administered, the name or other means of identifying the patient, such as medical record number or run number, and the identification of the individual administering the drug using either of the following methods:

(1) An electronic signature in a computerized recordkeeping system; or

(2) Any form of positive identification.

(E) Records of disposal of dangerous drugs from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and the positive identification of the EMS personnel that performed the disposal.

(F) Records for the disposal of controlled substance drugs shall be maintained in accordance with rule 4729:5-3-01 of the Administrative Code and, if disposal is performed on-site, the positive identification of the two EMS personnel who disposed of the drugs in accordance with rule 4729:5-14-03 of the Administrative Code.

Records for the disposal or destruction of the unused portion of a controlled substance resulting from administration to a patient from a licensee's stock or emergency supply shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date disposed, the method of disposal, and the positive identification of the two EMS personnel who disposed of the drugs.

(G) All records maintained in accordance with this rule shall be uniformly maintained and readily retrievable.

(H) An EMS organization shall conduct an annual inventory of all controlled substances in accordance with rule 4729:5-3-07 of the Administrative Code.

(I) Records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code shall contain the name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(J) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features to prevent unauthorized access to the records; and

(4) Contains daily back-up functionality to protect against record loss.

(K) Records of oxygen transfilling shall include the manufacturer's lot number of the oxygen used for transfilling the portable oxygen tanks.

Last updated December 1, 2025 at 9:56 AM

History

Effective: December 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-14-05 Protocols and Verbal Orders for Drug Administration.

(A) An emergency medical services professional with a certificate to practice and acting within their scope of practice may administer directly (but not prescribe) a dangerous drug, including controlled substances, outside the physical presence of a medical director or authorizing prescriber in accordance with the following:

(1) A protocol or standing order that is issued and adopted by one or more medical directors of the EMS organization; or

(2) A verbal order that is:

(a) Issued in accordance with a policy of the organization; and

(b) Provided by a medical director or an authorizing prescriber in response to a request by the emergency medical services professional with respect to a specific patient in any of the following circumstances:

(i) In the case of a mass casualty incident; or

(ii) To ensure the proper care and treatment of a specific patient.

(B) An emergency medical services professional with a certificate to practice and acting within their scope of practice may administer directly (but not prescribe) an initial dose of buprenorphine, or another medication for opioid use disorder approved by the board, to a patient who is experiencing opioid use disorder in accordance with a protocol approved by the organization's medical director. Such a protocol shall ensure that the EMS organization is able to provide a direct linkage to a program or prescriber who will continue the patient's therapy.

(C) A controlled substance administered in accordance with paragraph (B) of this rule is exempted from reporting to the drug database established in section 4729.75 of the Revised Code.

Last updated December 4, 2025 at 2:30 PM

History

Effective: December 1, 2025
Promulgated Under: 119.03

Chapter 4729:5-15 Animal Shelters

Ohio Adm.Code 4729:5-15-01 Animal shelters - definitions.

As used in Chapter 4729:5-15 of the Administrative Code:

(A) "Animal shelter" means a facility licensed as terminal distributor of dangerous drugs in accordance with section 4729.531 of the Revised Code or section 4729.54 of the Revised Code. An animal shelter shall be operated by a humane society or any society organized under Chapter 1717. of the Revised Code or a dog pound operated pursuant to Chapter 955. of the Revised Code and shall comply with all requirements set forth in this chapter.

(1) An animal shelter that does not have a licensed veterinarian serving as the responsible person shall obtain a limited license as terminal distributor of dangerous drugs in accordance with section 4729.531 of the Revised Code.

(2) An animal shelter shall ensure that all agents and employees who perform euthanasia, other than registered veterinary technicians or licensed veterinarians, shall successfully complete a euthanasia technician certification course described in section 4729.532 of the Revised Code.

(3) An animal shelter shall comply with the initial licensure and renewal requirements set forth in rule 4729:5-2-02 of the Administrative Code.

(4) The board may suspend, revoke, restrict, limit, or refuse to grant or renew any license issued to an animal shelter in accordance with rule 4729:5-4-01 of the Administrative Code.

(B) "Certified officer" means an individual who meets the requirements established under section 4729.534 of the Revised Code.

(1) Immobilize and capture;

(2) Attempt to immobilize and capture; or

(3) Attempt to immobilize or capture.

(D) "Chemical capture classification" means an authorization for a facility licensed as a terminal distributor of dangerous drugs in accordance with section 4729.532 of the Revised Code to purchase, possess, and administer a combination of drugs for chemical capture.

(E) "Companion animal" has the same meaning as in section 959.131 of the Revised Code.

(F) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(G) "County dog warden" means a dog warden or deputy dog warden appointed or employed under section 955.12 of the Revised Code.

(1) A county dog warden shall ensure that all agents and employees who perform euthanasia, other than registered veterinary technicians or licensed veterinarians, shall successfully complete a euthanasia technician certification course described in section 4729.532 of the Revised Code.

(2) A county dog warden shall comply with the initial licensure and renewal requirements set forth in rule 4729:5-2-02 of the Administrative Code.

(3) The board may suspend, revoke, restrict, limit, or refuse to grant or renew any license issued to a county dog warden in accordance with rule 4729:5-4-01 of the Administrative Code.

(H) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(I) "Euthanasia" has the same meaning as in paragraph (A) of rule 901:12-1-01 of the Administrative Code.

(J) "Euthanasia technician" is an individual that has successfully completed a euthanasia certification course, the curriculum of which has been approved by the veterinary medical licensing board pursuant to section 4729.532 of the Revised Code, and is in possession of a certificate which documents the successful completion of the certification course. For the purposes of this chapter, a euthanasia technician is considered a certified health care professional.

(K) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(L) "Personally furnish" or "personally furnishing" means the distribution of dangerous drugs by a prescriber to the prescriber's patients for use outside the prescriber's practice setting. For the purposes of this chapter, the prescriber shall be a veterinarian. A veterinarian at an animal shelter who personally furnishes a dangerous drug shall comply with the requirements of rule 4729:5-20-02 of the Administrative Code.

(M)

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(h) Other effective methods for identifying individuals that have been approved by the board.

(N) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(O) "Registered veterinary technician" has the same meaning as in section 4741.01 of the Revised Code.

(P) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

(Q) "Veterinarian" means an individual licensed by the state of Ohio to practice veterinary medicine pursuant to Chapter 4741. of the Revised Code.

Last updated July 29, 2026 at 4:16 PM

History

Effective: December 26, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-15-02 Security and control of dangerous drugs.

(A) The security and control of dangerous drugs is the responsibility of the responsible person on the terminal distributor of dangerous drugs license and the terminal distributor of dangerous drugs.

(B) Controlled substance dangerous drugs used to perform euthanasia or chemical capture shall be stored in a securely locked, substantially constructed cabinet or safe.

(1) The cabinet or safe shall be placed in an area that is not readily accessible to the public. The public does not include volunteers of the animal shelter.

(2) The cabinet or safe shall remain locked and secured when not in use.

(3) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(4) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a veterinarian, registered veterinary technician, responsible person, euthanasia technician, certified officer, dog warden, or executive director of the shelter. All locks shall be kept in good working order with keys removed therefrom.

(5) When not staffed by shelter personnel, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(6) Only a veterinarian, registered veterinary technician, euthanasia technician, executive director of the shelter, certified officer, dog warden, or the licensee's responsible person shall be able to access the cabinet or safe.

(C) Except as provided in paragraph (E) of this rule, controlled substance dangerous drugs that are not used to perform euthanasia or chemical capture shall be stored in a securely locked, substantially constructed cabinet or safe.

(1) The cabinet or safe shall be placed in a designated drug storage area that is not accessible by the public. The public does not include volunteers of the animal shelter.

(2) The cabinet or safe shall remain locked and secured when not in use.

(3) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(4) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a veterinarian if not being used by a veterinarian or a veterinary technician in accordance with paragraph (C)(6)(a), (C)(6)(b), or (C)(6)(c) of this rule. All locks shall be kept in good working order with keys removed therefrom.

(5) When not staffed by shelter personnel, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(6) Except as provided in paragraph (C)(6)(a), (C)(6)(b), or (C)(6)(c) of this rule, only a veterinarian shall be able to access the cabinet or safe.

(a) A veterinarian may provide a veterinary technician with a temporary key for the purposes of accessing the cabinet or safe. A veterinary technician shall return the key provided in accordance with this paragraph to the veterinarian or a secured location with restricted access (such as a lockbox) no later than the end of the technician's shift or if there is no longer a veterinarian available to provide personal supervision.

(b) A veterinarian may provide a veterinary technician with a key, combination or access code for the purposes of accessing the cabinet or safe, if all the following conditions apply:

(i) The cabinet or safe is maintained in a room secured by a physical barrier with suitable locks that can only be unlocked by a veterinarian;

(ii) The room is locked when not staffed by personnel or when there is no longer a veterinarian available to provide personal supervision.

(c) Any other method approved by the board's executive director or the director's designee that provides effective controls and procedures to guard against theft and diversion.

(D) Except as provided in paragraphs (B) and (E) of this rule, a registered veterinary technician may have access to controlled substances only under the personal supervision of a veterinarian.

(E) Employees or volunteers of an animal shelter or county dog warden that are designated by the responsible person or the shelter's executive director may have unsupervised access to controlled substances only under the following conditions:

(1) The drugs have been personally furnished by a veterinarian or dispensed by a pharmacy for direct administration to an animal.

(2) The drugs must be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, safe, or room. Access to the cabinet, safe, or room shall be limited to designated staff. The cabinet or safe must be separate from those required in paragraphs (B), (C), and (I) of this rule.

(a) The cabinet or safe shall be placed in an area that is not readily accessible to the public. The public does not include volunteers of the animal shelter or county dog warden.

(b) The cabinet, safe, or room shall remain locked and secured when not in use.

(c) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than designated staff. All locks shall be kept in good working order with keys removed therefrom.

(d) When not staffed by shelter personnel, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(3) A record of drug administration shall be maintained in accordance with paragraph (E) of rule 4729:5-15-03 of the Administrative Code.

(4) The responsible person shall report the theft or significant loss of drugs maintained pursuant to this paragraph in accordance with rule 4729:5-3-02 of the Administrative Code.

(5) The responsible person or shelter's executive director shall maintain a current list of all designated employees or volunteers for immediate inspection by an agent, officer or inspector of the board.

(F) Non-controlled dangerous drugs that have been personally furnished by a veterinarian or dispensed by a pharmacy for direct administration may be administered by an animal shelter or county dog warden employee or volunteer.

(G) Only a veterinarian shall have access to uncompleted prescription blanks used for writing a prescription. Uncompleted prescription blanks shall be secured when not in use.

(H)

(1) For an animal shelter or county dog warden that is licensed in accordance with section 4729.54 of the Revised Code: personnel authorized by the responsible person may have access to D.E.A. controlled substance order forms only under the personal supervision of a veterinarian. D.E.A. controlled substance order forms shall be secured when not in use.

(2) For an animal shelter or county dog warden that is licensed in accordance with section 4729.531 of the Revised Code: personnel authorized by the responsible person may have access to D.E.A. controlled substance order forms only under the personal supervision of the responsible person. D.E.A. controlled substance order forms shall be secured when not in use.

(I) Thiafentanil, carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a separate safe or steel cabinet equivalent to a U.S. government class V security container from all other controlled substances.

(2) Except as provided for in this paragraph, the cabinet or safe shall be placed in a designated drug storage area that is not accessible by the public. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, patients, business guests, or visitors to be present in or pass through areas containing the cabinet or safe, a veterinarian or veterinary technician shall provide for adequate observation of the area.

(3) The cabinet or safe shall remain locked and secured when not in use.

(4) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(5) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a veterinarian if not being used by a veterinarian. All locks shall be kept in good working order with keys removed therefrom.

(6) When not staffed by personnel, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(7) Only a veterinarian shall be able to access the safe or cabinet.

(J) When not staffed by personnel, hypodermics shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, locked room, or secured facility. During normal business hours, hypodermics shall not be stored in areas where members of the public are not supervised by individuals authorized to administer injections. Members of the public do not include volunteers of the animal shelter or county dog warden.

(K) When not staffed by personnel, non-controlled dangerous drugs shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, locked room, or secured facility. During normal business hours, non-controlled dangerous drugs shall not be stored in areas where members of the public are not supervised by individuals authorized to administer such drugs. Members of the public do not include volunteers of the animal shelter or county dog warden.

(L) In the event of a change of ownership of an animal, an employee or volunteer may transfer dangerous drugs that have been personally furnished by a veterinarian or dispensed by a pharmacy for direct administration to an animal to the animal's new owner or caregiver. The transfer of controlled substances shall be documented in accordance with paragraph (I) of rule 4729:5-15-03 of the Administrative Code.

(M) All records relating to the receipt, administration, distribution, personal furnishing and sale of dangerous drugs shall be maintained under appropriate supervision and control to restrict access by those who neither work for, or volunteer at, the animal shelter or county dog warden.

(N) All areas where dangerous drugs and devices are stored shall be dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the drugs prior to use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Refrigerators and freezers used for the storage of drugs and devices shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs.

(O) Upon the initial puncture of a multiple-dose vial containing a drug, the vial shall be labeled with a date opened. Multiple-dose vials shall be examined prior to use for evidence of physical or chemical contamination. Vials that have any of the following characteristics shall be deemed adulterated:

(1) Contain particulate matter, precipitates, turbidity, or discoloration;

(2) Mislabeled; or

(3) Noticeable coring (damage to the rubber stopper).

(P) Adulterated drugs, including expired drugs, shall be stored in accordance with rule 4729:5-3-06 of the Administrative Code.

(Q) Disposal of controlled substances shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code.

(R) Disposal of non-controlled dangerous drugs shall be conducted in accordance with rule 4729:5-3-06 of the Administrative Code.

Last updated July 20, 2026 at 4:39 PM

History

Effective: December 26, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-15-03 Record keeping.

(A) An animal shelter or county dog warden shall keep a record of all dangerous drugs received, administered, personally furnished, disposed, sold or transferred.

(C) Records of temperature control monitoring described in paragraph (N) of rule 4729:5-15-02 of the Administrative Code shall include any of the following:

(1) For temperature logs, either:

(a) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(b) For systems that provide automated temperature monitoring, maintain a report that provides, at a minimum, the date and time of observation and the temperature recorded.

(D) Records of personally furnishing shall contain the name, strength, dosage form, and quantity of the dangerous drugs personally furnished, the name or identification of the animal, name and address of the animal's owner or caregiver if the owner or caregiver is not the animal shelter, the date the drug is personally furnished and, if applicable, the date the drug is received by the animal's owner or caregiver. A veterinarian shall be required to document the final association of a controlled substances dangerous drug with a patient using positive identification

(E)

(1) Records of administration or use shall contain the name, strength, dosage form, and quantity of the dangerous drugs administered, the name or identification of the animal to whom or for whose use the dangerous drugs were administered, and the date of administration. For controlled substance dangerous drugs, the administration record shall also include the positive identification of the person administering the drug.

(2) Records of dangerous drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(3) Orders for the administration of controlled substances shall be documented using positive identification. An order that is a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(4) Paragraph (E)(3) of this rule does not apply in any of the following instances:

(a) Administration of dangerous drugs authorized under Chapter 4729. of the Revised Code to perform euthanasia by means of lethal injection by a veterinarian, registered veterinary technician, or euthanasia technician;

(b) Administration of dangerous drugs pursuant to paragraph (E) of rule 4729:5-15-02 of the Administrative Code; and

(F) Records of disposal of dangerous drugs from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and the identification of the person that performed the disposal.

(G) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory, including drugs maintained in accordance with paragraph (E) of rule 4729:5-15-02 of the Administrative Code, is performed on-site, records shall also include the positive identification of two persons conducting and witnessing the disposal, one of whom shall be the responsible person or a veterinarian, registered veterinary technician, or certified euthanasia technician.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient or controlled substances maintained in accordance with paragraph (E) of rule 4729:5-15-02 of the Administrative Code, records shall also include the positive identification of two persons conducting and witnessing the disposal, one of whom shall be the responsible person or a veterinarian, registered veterinary technician, or certified euthanasia technician.

(H) Records of transfer or sale conducted in accordance with chapter 4729. of the Revised Code and rule 4729:5-3-09 of the Administrative Code shall contain the name, strength, dosage form, expiration date, and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(I) Records of controlled substances transferred in accordance with paragraph (L) of rule 4729:5-15-02 of the Administrative Code shall contain the name, strength, dosage form, and quantity of the dangerous drugs transferred, the name or identification of the animal, name and address of the animal's owner or caregiver if the owner or caregiver is not the animal shelter, the positive identification of the animal shelter employee or volunteer transferring the drug, the date the drug is transferred, and the date the drug is received by the animal's owner or caregiver.

(J) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

(K) In addition to the inventory requirements set forth in rule 4729:5-3-07 of the Administrative Code, the responsible person for an animal shelter that maintains controlled substance dangerous drugs used to perform euthanasia listed in paragraph (B) of rule 4729:5-15-04 of the Administrative Code shall be responsible for completing a monthly inventory, in accordance with rule 4729:5-3-07 of the Administrative Code, of those drugs to deter and detect diversion.

(L) An animal shelter or county dog warden licensed as a limited category II or limited category III terminal distributor of dangerous drugs may only possess dangerous drugs that are on the drug list submitted to the board pursuant to section 4729.54 of Revised Code and only at locations licensed by the state board of pharmacy. The responsible person may modify the drugs that may be possessed and administered by the limited facility by submitting a new drug list to the state board of pharmacy in a manner determined by the board.

(M) All records maintained in accordance with this rule and rule 4729:5-15-02 of the Administrative Code shall be readily retrievable and shall be kept on-site for a period of three years.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(N) All records maintained pursuant to this rule and rule 4729:5-15-02 of the Administrative Code may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) Complies with the requirements of this rule;

(2) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features, such as unique user names and passwords, to prevent unauthorized access; and

(4) Contains daily back-up functionality to protect against record loss.

Last updated July 20, 2026 at 4:39 PM

History

Effective: December 26, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-15-04 Drugs approved for euthanasia.

(A) Pursuant to section 4729.532 of the Revised Code, except for a licensed veterinarian or registered veterinary technician, no agent or employee of an animal shelter and no county dog warden or agent or employee of a county dog warden shall perform euthanasia by means of lethal injection on an animal by use of any substance other than a substance in a manufactured dosage form that the state veterinary medical licensing board has approved under chapter 4741. of the Administrative Code.

(B) Before euthanasia, a euthanasia technician may administer a solution of one or more of the following drugs exclusively for the purpose of inducing anesthesia, sedation, or unconsciousness prior to euthanasia:

(1) Ketamine;

(2) Tiletamine and zolazepam; and

(3) Xylazine.

Last updated July 20, 2026 at 4:39 PM

History

Effective: December 26, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-15-05 Chemical capture classification.

(A) Upon application of an animal shelter or county dog warden that holds a limited license issued under section 4729.531 of the Revised Code, the state board of pharmacy may grant a chemical capture classification to the limited license. The classification permits the holder to purchase, possess, and administer a combination of drugs for chemical capture. Unless otherwise approved by the board, no such classification shall authorize or permit the distribution of these drugs to any person other than the originating wholesale distributor of the drugs.

(1) To qualify for a chemical capture classification under this rule, an applicant shall appoint or employ a certified officer.

(2) An animal shelter or county dog warden shall comply with the initial licensure and renewal requirements set forth in rule 4729:5-2-02 of the Administrative Code. As part of this licensing process, the animal shelter or county dog warden shall provide a list of drugs, signed by the responsible person, that will be used for chemical capture.

(3) A certified officer may use any of the following drugs for use as part of the chemical capture process:

(a) Ketamine;

(b) Xylazine;

(d) Yohimbine;

(e) Tolazoline; and

(f) Atipamezole.

(B) All areas where drugs and devices used for chemical capture are stored shall comply with the security and storage requirements of rule 4729:5-15-02 of the Administrative Code and rule 4729:5-3-13 of the Administrative Code.

(1) Recordkeeping requirements of rule 4729:5-15-03 of the Administrative Code; and

(2) Drug disposal requirements of rule 4729:5-15-02 of the Administrative Code.

(D) The animal shelter or dog warden shall develop and implement a drug dosing protocol for all drugs and equipment used in chemical capture.

(1) The protocol shall be reviewed and signed by a veterinarian licensed under Chapter 4741. of the Revised Code.

(2) The protocol shall include the following: drug, dose, concentration, approved uses for drug delivery, approved equipment for use, circumstances for use, contraindications, any known common complications/side effects, and weight ranges with corresponding volume of drug to be administered.

(3) A documented review of the protocol shall be conducted by a veterinarian licensed under Chapter 4741. of the Revised Code at least once every five years.

(E) All equipment used in chemical capture shall:

(1) Be secured to prevent unauthorized access by individuals who are not certified officers;

(2) Maintained and used in accordance with the manufacturer's instructions and the protocol established in accordance with paragraph (D) of this rule.

(3) Be disposed of in accordance with the manufacturer's instructions.

(F) An animal shelter or dog warden with a chemical capture classification shall develop and implement policies and procedures that incorporate the following based upon nationally recognized standards for chemical capture:

(1) Determining when chemical capture is appropriate. Such policies and procedures shall make all reasonable efforts to ensure animal safety, certified officer safety, and the safety of the public.

(2) The care of a companion animal immediately upon capture. Certified officers engaged in chemical capture must have a written animal handling and post capture protocol which includes:

(a) The procedure for removing the dart from a captured animal;

(b) First aid for the animal, with particular reference to the dart wound and potential emergencies (including: hyperthermia, hypothermia, shock, bloat, respiratory distress, and cardiac arrest); and

(G) A terminal distributor of dangerous drugs with a chemical capture classification shall maintain records for every certified officer that has completed training in accordance section 4729.534 of the Revised Code. Such documentation shall be made readily retrievable and shall be maintained for one year from the date the certified officer is no longer employed by or affiliated with the terminal distributor of dangerous drugs.

Last updated July 20, 2026 at 4:39 PM

History

Effective: January 23, 2023
Promulgated Under: 119.03

Chapter 4729:5-16 Laboratories

Ohio Adm.Code 4729:5-16-01 Laboratories - definitions.

As used in Chapter 4729:5-16 of the Administrative Code:

(A) "Laboratory" means any facility licensed as a terminal distributor of dangerous drugs in accordance with section 4729.54 of the Revised Code where dangerous drugs and controlled substances are possessed for scientific, clinical, or instructional purposes. The facility shall comply with all requirements set forth in this chapter. A laboratory does not include any of the following:

(1) A laboratory licensed under Chapter 3796. of the Revised Code; or

(2) Any other person or facility licensed as a terminal distributor of dangerous drugs that is specifically defined and required to comply with another chapter of this division (EMS organization, veterinary clinic, pain management clinic, animal shelter, etc.).

(B) "Anonymous sample" means an unknown substance submitted to a laboratory for qualitative and/or quantitative analysis.

(C) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code but shall not include exempt chemical preparations as defined in paragraph (E) of this rule.

(D) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(E) "Exempt chemical preparation" means a chemical or compound approved by the United States drug enforcement administration pursuant to 21 CFR 1308.23 (12/30/2016).

(F) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as in rule 4729:5-1-02 of the Administrative Code but shall be limited to a prescriber practicing within the prescriber's applicable scope of practice.

(G) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(H) "Personally furnish" or "personally furnishing" means the final association of a drug with a patient by a prescriber prior to the distribution to a patient for use outside the prescriber's practice setting. A prescriber at a laboratory who personally furnishes a dangerous drug shall comply with the requirements of rule 4729:5-19-02 or 4729:5-20-02 of the Administrative Code.

(I)

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board system of randomly generated personal questions;

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier.

(J) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer, or inspector of the board.

(K) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs and controlled substances as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and controlled substances, and maintaining all drug records otherwise required.

Last updated April 1, 2026 at 8:33 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-16-02 Security, control and storage of dangerous drugs.

(A) The security and control of dangerous drugs and controlled substances is the responsibility of the responsible person on the terminal distributor of dangerous drugs license and the terminal distributor.

(B) Except as provided in paragraph (H) of this rule, controlled substances shall be stored in a securely locked, substantially constructed cabinet or safe to deter and detect unauthorized access.

(1) The cabinet or safe shall be placed in an area that is not readily accessible to the public.

(2) The cabinet or safe shall remain locked and secured when not in use.

(3) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(4) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than the responsible person or the responsible person's designee if not being used by the responsible person, responsible person's designee, or a laboratory employee or researcher in accordance with paragraph (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule. All locks shall be kept in good working order with keys removed therefrom.

(5) When the laboratory is not in use by authorized personnel, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(6) Except as provided in paragraph (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule, only the responsible person or the responsible person's designee shall have possession of keys, combinations, or access codes to the cabinet or safe.

(a) A responsible person or the responsible person's designee may provide a laboratory employee or researcher with a temporary key for the purposes of accessing the cabinet or safe. An employee or researcher shall return the key provided in accordance with this paragraph to the responsible person or responsible person's designee or a secured location with restricted access (such as a lockbox) no later than the end of the employee's shift, the end of the researcher's activity, or if there is no longer a responsible person or designee available to provide personal supervision.

(b) A responsible person or the responsible person's designee may provide an employee or researcher with a key, combination, or access code for the purposes of accessing the cabinet or safe, if all the following conditions apply:

(i) The cabinet or safe is maintained in a room secured by a physical barrier with suitable locks that can only be unlocked by the responsible person or the responsible person's designee;

(ii) The room is locked during non-business hours or when there is no longer a responsible person or responsible person's designee available to provide personal supervision.

(c) Any other method approved by the board's executive director or the director's designee that provides effective controls and procedures to guard against theft and diversion.

(C) An employee or researcher of the laboratory may have access to controlled substances only under the personal supervision of the laboratory's responsible person or the responsible person's designee. A responsible person may have more than one designee. All designees shall meet the requirements of the responsible person set forth in rule 4729:5-2-01 of the Administrative Code. A laboratory shall maintain a current list of all approved designees for immediate inspection by an agent, officer, or inspector of the board.

(D) Only a prescriber shall have access to uncompleted prescription blank(s) used for writing a prescription. Uncompleted prescription blank(s) shall be secured when not in use.

(E) Personnel authorized by the responsible person may have access to D.E.A. controlled substance order forms under the personal supervision of the laboratory's responsible person. D.E.A. controlled substance order forms shall be secured when not in use.

(F) Controlled substances in the process of testing, use, or research shall be returned to the required storage location upon completion of each such process.

(G) All samples containing, or suspected of containing, a dangerous drug or controlled substance shall be treated as schedule I and II controlled substances.

(H) Thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine shall be stored in a separate safe or steel cabinet equivalent to a U.S. government class V security container from all other controlled substances.

(2) The cabinet or safe shall be placed in an area that is not readily accessible to the public.

(3) The cabinet or safe shall remain locked and secured when not in use.

(5) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than the responsible person or the responsible person's designee if not being used by the responsible person or the responsible person's designee. All locks shall be kept in good working order with keys removed therefrom.

(6) When the laboratory is not in use by authorized personnel, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(7) Only the responsible person or the responsible person's designee shall have possession of the key, combination, or access code to the safe or cabinet.

(8) This paragraph does not apply to exempt chemical preparations as defined in rule 4729:5-16-01 of the Administrative Code.

(I) When the laboratory is not in use by authorized personnel, non-controlled dangerous drugs, exempt chemical preparations, and hypodermics shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet or safe, drawer, locked room, or secured facility.

(J) All records relating to the administration, distribution, personal furnishing, and sale of dangerous drugs and controlled substances shall be maintained under appropriate supervision and control to restrict unauthorized access.

(K) All areas where dangerous drugs and controlled substances are stored shall be dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Unless otherwise required by a documented research study, storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the drugs prior to use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Refrigerators and freezers used for the storage of drugs and controlled substances shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored drugs and controlled substances.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs and controlled substances.

(M) Adulterated drugs, including expired drugs, shall be stored in accordance with rule 4729:5-3-06 of the Administrative Code. This paragraph does not apply to drugs submitted to crime laboratories for analysis or laboratories conducting research using adulterated drugs.

(N) Laboratories shall comply with all state and federal laws, rules, and regulations governing the use of controlled substances for the purpose of research or chemical analysis.

(O) Unless consumed as part of an analysis, disposal of controlled substance dangerous drugs shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code.

(P) Unless consumed as part of an analysis, disposal of non-controlled dangerous drugs shall be conducted in accordance with rule 4729:5-3-06 of the Administrative Code.

(Q) Unless consumed as part of an analysis, disposal of controlled substances that are not dangerous drugs or any unused portion of a submitted anonymous sample for scientific analysis shall be conducted as follows:

(1) The method of disposal shall render the drug or substance non-retrievable as defined in rule 4729:5-3-01 of the Administrative Code.

(2) Disposal shall be conducted by any of the following:

(a) The responsible person or the responsible person's designee and one other employee of the laboratory;

(b) Two employees of the laboratory designated by the responsible person; or

(3) Records for the disposal of the drug or substance shall contain the actual identification of the drug or substance, form, and quantity disposed; the date disposed; the method of disposal; and, if disposal is conducted on-site, the positive identification of the two personnel conducting and witnessing the disposal.

Last updated April 1, 2026 at 8:33 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-16-03 Record keeping.

(A) A laboratory shall keep a record of all dangerous drugs and controlled substances received, administered, personally furnished, used (i.e. chemical analysis or research), disposed, destroyed, or transferred.

(B) The acts of administering, using (e.g., chemical analysis or research), and destroying or disposing controlled substances shall be documented with positive identification.

(C) Records of receipt shall contain a description of the drug or substance and all the following if obtained from a person licensed in accordance with section 4729.52 or 4729.54 of the Revised Code:

(1) The name, strength, dosage form, and quantity of the drug;

(2) The name and address of the seller;

(3) The name and address of the recipient; and

(4) The date of receipt.

(D) Except as provided in paragraph (E) of this rule, records of personally furnishing shall contain the name, strength, dosage form, and quantity of the dangerous drugs personally furnished; the positive identification of the person personally furnishing the drug; the name, address and date of birth of the person to whom or for whose use the dangerous drug were personally furnished; the date the drug is personally furnished; and, if applicable, the date the drug is received by the patient or patient's caregiver.

(E) Records of personally furnishing for animal use shall contain the name, strength, dosage form, and quantity of the dangerous drugs personally furnished; the positive identification of the person personally furnishing the drug; the name of the animal or group of animals (e.g., herd, parliament, flock, flamboyance); the name and address of the owner of the animal or animals; the date the drug is personally furnished; and, if applicable, the date the drug is received by the animal's owner or caregiver.

(F) Except as provided in paragraphs (G) and (H) of this rule, records of administration shall contain the name, strength, dosage form, and quantity of the drugs administered; the name and date of birth of the person to whom or for whose use the drugs were administered; the identification of the person administering the drug; and the date of administration.

(1) Records of drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(2) Records of controlled substances administered shall be documented using positive identification.

(3) Records of dangerous drugs administered by a health care professional, acting within the professional's scope of practice, who is not a prescriber shall include documentation of an order or protocol issued by a prescriber authorizing the administration of the drug. An order that is a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph. Orders for the administration of controlled substances shall be documented using positive identification.

(G) Except as provided in paragraph (H) of this rule, records of administration for animal use shall contain the name, strength, dosage form, and quantity of the drugs administered; the name or identification number of the animal to whom or for whose use the drugs were administered; the identification of the person administering the drug; and the date of administration.

(1) Records of drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(2) Records of controlled substances administered shall be documented using positive identification.

(3) Records of dangerous drugs administered by a health care professional, acting within the professional's scope of practice, who is not a prescriber shall include documentation of an order or protocol issued by a prescriber authorizing the administration of the drug. An order that is a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph. Orders for the administration of controlled substances shall be documented using positive identification.

(H) Records of administration for non-human research purposes shall contain the name of the drugs administered; the name or identifier of the animal, group of animals, or group of cells for whose use the drugs were administered; the identification of the person administering the drug; and the date the research protocol began. Administration to an animal or group of animals shall be pursuant to an institutional animal care and use committee (IACUC) protocol which outlines the name, strength, dosage form, and quantity of the drug to be administered, and a timeline for subsequent administration(s). Documentation within a lab notebook or research record shall be deemed to meet the requirements of this paragraph.

(1) The laboratory shall have the current IACUC protocol available for immediate inspection by an agent, inspector, or employee of the board.

(2) Records of controlled substances administered shall be documented using positive identification.

(I) A laboratory conducting chemical analysis or research with dangerous drugs or controlled substances shall maintain records with the following information for each dangerous drug or controlled substance:

(1) The name of the drug or controlled substance.

(2) The form (e.g., powder, granulation, tablet, capsule, or solution) and the concentration in such form (e.g., "C.P.," "U.S.P.," "N.F.," ten-milligram tablet, or ten-milligram concentration per milliliter).

(3) The quantity utilized in any manner by the laboratory including the date and manner of utilization.

(4) The identification of the person or persons conducting the chemical analysis or research. If a controlled substance, the positive identification of the person or persons conducting the chemical analysis or research.

(5) This paragraph does not apply to records relating to known or suspected controlled substances or dangerous drugs received as evidentiary material.

(J) A laboratory conducting chemical analysis of anonymous samples of suspected controlled substances or dangerous drugs shall maintain records, to the extent known and reasonably ascertainable by the person conducting the analysis, containing the following information:

(1) Date the sample is received;

(2) Purported contents and actual identification;

(3) Quantity received;

(4) Form of sample (i.e., powder, liquid, tablets, etc.);

(5) Description of sample;

(6) Quantity utilized in analysis; and

(7) The identification of the person or persons conducting the analysis.

(K) Records of dangerous drug disposal, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug destroyed; the date destroyed; the method of disposal; and the identification of the person that performed the disposal.

(L) Records of controlled substance dangerous drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance dangerous drug inventory is performed on-site, records shall also include the positive identification of two laboratory employees conducting and witnessing the disposal, one of whom shall be the responsible person or the responsible person's designee.

(2) If conducting the disposal of an unused portion of a controlled substance dangerous drug, records shall also include the positive identification of two laboratory employees conducting and witnessing the disposal.

(M) Records of the disposal of controlled substances that are not dangerous drugs or any unused portion of a submitted anonymous sample shall be maintained in accordance with paragraph (Q) of rule 4729:5-16-02 of the Administrative Code.

(N) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

(O) Records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code shall contain the name, strength, dosage form, national drug code, and quantity of the dangerous drug transferred or sold; the address of the location where the drugs were transferred or sold; and the date of transfer or sale.

(P) Records of temperature control monitoring described in paragraph (K)(1) of rule 4729:5-16-02 of the Administrative Code shall include any of the following:

(1) For temperature logs, either:

(a) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(b) For systems that provide automated temperature monitoring, maintain a report that provides, at a minimum, the date and time of observation and the temperature recorded.

(Q) All records maintained in accordance with this rule shall be readily retrievable and shall be kept on-site for a period of three years.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(R) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) Complies with the requirements of this rule;

(2) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features, such as unique user names and passwords, to prevent unauthorized access to the records; and

(4) Contains daily back-up functionality to protect against record loss.

Last updated April 1, 2026 at 8:33 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Chapter 4729:5-17 Medical Oxygen, Nitrous Oxide, Medical Gases and Dialysis Solutions

Ohio Adm.Code 4729:5-17-01 Medical Oxygen, Nitrous Oxide, Medical Gases and Dialysis Solutions - Definitions.

As used in Chapter 4729:5-17 of the Administrative Code:

(A) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as in rule 4729:5-1-02 of the Administrative Code but shall be limited to a prescriber practicing within the prescriber's applicable scope of practice.

(B) "Medical oxygen" means oxygen that meets the definition of a dangerous drug pursuant to section 4729.01 of the Revised Code.

(C) "Peritoneal dialysis solution" or "dialysis solution" means a commercially manufactured, unopened, sterile dangerous drug solution that is intended to be instilled into the peritoneal cavity during the medical procedure known as peritoneal dialysis.

(D) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(E) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs and medical gases as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and medical gases, and maintaining all drug records otherwise required.

(F) "Tamper-evident" means a package, storage container or other physical barrier is sealed or secured in such a way that access to medical gases or dangerous drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

(G) The provisions of this chapter do not apply to a person or facility licensed as a terminal distributor of dangerous drugs that is specifically defined and required to comply with another chapter of this division (EMS organization, veterinary clinic, prescriber clinic, pain management clinic, animal shelter, etc.).

Last updated December 2, 2024 at 1:42 PM

History

Effective: September 1, 2019
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-17-02 Medical oxygen - general provisions.

(A) Except as provided in paragraph (H) of this rule, each person, whether located within or outside of this state, who conducts retail sales of medical oxygen in this state shall obtain a limited category II terminal distributor of dangerous drugs license.

The requirements of this paragraph do not apply to persons currently licensed to purchase, possess, and sell dangerous drugs at retail in accordance with division 4729:5 of the Administrative Code or who are exempted from licensure in accordance with section 4729.541 of the Revised Code.

(B) All areas where medical oxygen is stored shall be maintained in a clean and orderly condition. Storage areas shall be maintained at conditions and temperatures which will ensure the integrity of the medical oxygen prior to use as stipulated by the manufacturer's or distributor's labeling.

(D) All retail sellers of medical oxygen shall maintain records of the purchase of oxygen at wholesale and the sale of oxygen at retail, including prescriber orders, for three years at the licensed location. All records shall be readily retrievable.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(E) A terminal distributor of dangerous drugs shall report the theft or significant loss of medical oxygen pursuant to rule 4729:5-3-02 of the Administrative Code.

(F) Except as provided in paragraphs (G) and (H) of this rule, prior to making an initial sale of medical oxygen to a patient, a terminal distributor of dangerous drugs must have an order issued by a prescriber.

(1) The order must include the full name and address of the patient, the signature of the prescriber, the manually printed, typewritten, electronically generated or preprinted full name and address of the prescriber, the telephone number where the prescriber can be personally contacted during normal business hours, the date of issuance, and documentation of need. A terminal distributor may add the patient's address, prescriber's address, and prescriber's phone number to the order if incomplete on the original order.

(2) The prescriber's order may be transmitted electronically to the retail seller.

(3) All orders issued in accordance with this paragraph are valid for a period of one year from the date of issuance.

(G) S.C.U.B.A. divers who hold a valid certificate in the following nationally recognized S.C.U.B.A. diving certifying organization programs may purchase, possess, and use medical oxygen for the purpose of emergency care or treatment at the scene of a diving emergency pursuant to section 4729.541 of the Revised Code:

(1) Diver alert network (DAN): oxygen first aid for scuba diving injuries;

(2) International association of nitrox and technical divers: oxygen provider course;

(3) Professional association of diving instructors (PADI): emergency first response;

(4) PADI: PADI oxygen first aid;

(5) PADI: rescue diver course;

(6) PADI: tec deep diver;

(7) Scuba schools international: medic first aid emergency oxygen administration;

(8) Technical diving international-S.C.U.B.A. diving international: diver advanced development program as a CPROX administrator;

(9) YMCA: slam rescue;

(10) National association of underwater instructors (NAUI) first aid;

(11) NAUI rescue scuba diver;

(12) NAUI advanced rescue scuba diver;

(13) NAUI first aid instructor;

(14) NAUI oxygen administration;

(15) NAUI instructor; and

(16) Any other program as approved by the board.

(H)

(1) In accordance with policy guidance issued by the United States food and drug administration, oxygen equipment intended for emergency use may be sold without a prescription.

(a) Such equipment shall deliver a minimum flow rate of six liters of oxygen per minute for a minimum of fifteen minutes.

(b) Labeling for emergency oxygen shall not contain references to heart attacks, strokes, shock or any other medical condition amenable to diagnosis or treatment only by a licensed health care professional.

(c) Oxygen units delivering a minimum flow rate of less than six liters of oxygen per minute for a period less than fifteen minutes and labeled for emergency use are considered adulterated and misbranded.

(d) If the units are not intended for emergency use and provide less than six liters of oxygen per minute or are labeled for human use for other than emergency use, such units are regarded as a dangerous drug and shall bear the prescription legend.

(e) The units shall contain no more than eighty minutes (four hundred eighty liters) of USP oxygen.

(2) Persons that only sell oxygen equipment intended for emergency use that meet the criteria listed in paragraph (H)(1) of this rule shall not be required to obtain licensure as a terminal distributor of dangerous drugs in accordance with paragraph (A) of this rule.

(3) Persons that possess and administer oxygen equipment intended for emergency use that meet the criteria listed in paragraph (H)(1) of this rule shall not be required to obtain licensure as a terminal distributor of dangerous drugs.

Last updated July 14, 2025 at 9:24 AM

History

Effective: May 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-17-03 Nitrous oxide - general provisions.

(A) Each person, whether located within or outside of this state, who conducts retail sales of nitrous oxide in this state shall obtain a limited category II terminal distributor of dangerous drugs license.

(B) All areas where nitrous oxide is stored shall be maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the nitrous oxide prior to use as stipulated by the manufacturer's or distributor's labeling.

(D) All retail sellers of nitrous oxide shall maintain records of the purchase of nitrous oxide at wholesale and the sale of nitrous oxide at retail for three years at the licensed location. All records shall be readily retrievable.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(E) A terminal distributor of dangerous drugs shall report the theft or significant loss of nitrous oxide pursuant to rule 4729:5-3-02 of the Administrative Code.

Last updated May 1, 2025 at 7:56 AM

History

Effective: May 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-17-04 Compressed medical gasses - general provisions and safety program.

(A) Each person, whether located within or outside this state, who seeks to possess or sell compressed medical gases, including medical oxygen and nitrous oxide, in this state shall maintain, based upon the person's business activities, a wholesale distributor of dangerous drugs license in accordance with section 4729.52 of the Revised Code, a terminal distributor of dangerous drugs license in accordance with section 4729.54 of the Revised Code, or are exempted in accordance with section 4729.541 of the Revised Code.

(B) Wholesale or terminal distributors of dangerous drugs who fill containers with compressed medical gases must comply with the current good manufacturing practice regulations issued pursuant to the Federal Food, Drug and Cosmetic Act (4/1/2018) and the current regulations and guidelines issued pursuant to Title 21 CFR 10.90 (4/1/2018).

(C) Records required by state and federal laws, rules, and regulations governing the sale of dangerous drugs and the filling of containers with compressed medical gases shall be maintained for a period of three years at the licensed location. All records shall be readily retrievable.

(1) A wholesale or terminal distributor of dangerous drugs intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the wholesale or terminal distributor of dangerous drugs.

(D) A terminal distributor of dangerous drugs shall report the theft or significant loss of compressed medical gasses pursuant to rule 4729:5-3-02 of the Administrative Code.

(E) A wholesale distributor of dangerous drugs shall report the theft or significant loss of compressed medical gasses pursuant to rule 4729:6-3-02 of the Administrative Code.

(F) A medical gases safety program developed pursuant to section 4729.70 of the Revised Code shall comply with the following requirements:

(1) The instructors shall have the appropriate education and experience to teach a program in medical gas safety.

(2) The program shall be presented to all individuals who fill, install, connect, or disconnect medical gases contained in cryogenic vessels that are portable and intended for use in administering direct treatment to one or more individuals.

(3) Successful participation and demonstrated competency in a program must be completed prior to an individual filling, installing, connecting, or disconnecting a medical gas contained within a cryogenic vessel.

(4) The program must include the following:

(a) The description of a cryogenic vessel, including:

(i) Valve inlet and outlet connections;

(ii) Safety systems associated with each outlet;

(iii) Proper labeling;

(iv) Color coding; and

(v) Gas identification.

(b) A review of each medical gas listed in division (C)(2) of section 4729.70 of the Revised Code that may be contained in a cryogenic vessel, including:

(i) A description of the properties of the gas or liquid;

(ii) The precautions and warnings associated with the gas or liquid;

(iii) Procedures for handling exposure to the gas or liquid; and

(iv) Procedures to handling the gas or liquid during an emergency.

(i) Connecting and disconnecting supply lines;

(ii) Recognizing silver-brazed fittings or other acceptable mechanical means that make the connection a permanent and integral part of the valve;

(iii) Recognizing that changing or adapting the fittings for another gas service is strictly prohibited except in accordance paragraph (H) of this rule;

(iv) Recognizing the appropriate devices through which medical gases are delivered from cryogenic vessels;

(v) Detecting and reporting leaks;

(vi) Transporting cryogenic vessels appropriately within a facility; and

(vii) Appropriate storage of cryogenic vessels.

(5) The program instructor must document the participation of an individual in a medical gases safety program. The documentation must be maintained by the individual's employer for a period of at least three years and made readily retrievable.

(6) Individuals who install, connect, or disconnect medical gases from cryogenic vessels must attend a medical gases safety program at least once every two years.

(G) No person shall modify a cryogenic vessel, connection, or valve or adapt a connection for another gas service pursuant to division (D) of section 4729.70 of the Revised Code.

(H) Paragraph (G) of this rule does not apply to an employee or agent of a firm owning the cryogenic vessel and who is charged with the responsibility of conducting applicable vessel maintenance, changing service from one medical gas to another, or bringing a vessel into compliance with section 4729.70 of the Revised Code.

(1) Such employee or agent shall meet the following requirements:

(a) Successful completion of a medical gases safety program pursuant to paragraph (F) of this rule.

(b) Successful participation and demonstrated competency in a cryogenic vessel modification program administered by an instructor with the appropriate education and experience. The program must be based on written and validated procedures. The employee or agent must participate in the program annually and the program shall include the following:

(i) Removing, adding, or adapting cryogenic vessel connections and valves;

(ii) Modifying cryogenic vessels;

(iii) Conducting cryogenic vessel maintenance;

(iv) Changing the cryogenic vessel from one medical gas to another;

(v) Bringing a cryogenic vessel into compliance with section 4729.70 of the Revised Code;

(vi) Silver brazing or welding techniques and certification of the individual if applicable; and

(vii) Removing and adding suitable mechanical means to make a connection a permanent and integral part of the valve.

(2) An employer must document the successful participation and demonstrated competency of an employee or agent in a cryogenic vessel modification program. The documentation must be maintained by the employer for a period of at least three years and made available, upon request, to those business entities receiving service and to the state board of pharmacy.

Last updated May 1, 2025 at 7:56 AM

History

Effective: May 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-17-05 Dialysis solutions - general provisions.

(A) Each person, whether located within or outside this state, who sells peritoneal dialysis solutions in this state shall obtain a limited category II terminal distributor of dangerous drugs license. The requirements of this paragraph do not apply to persons currently licensed to purchase, possess, and sell dangerous drugs at retail in accordance with division 4729:5 of the Administrative Code.

(B) All areas where dialysis solution is stored shall be dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the dialysis solution prior to use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(D) All retail sellers of peritoneal dialysis solutions shall maintain records of purchase of dialysis solutions at wholesale and sale of dialysis solutions at retail for three years at the licensed location. All records shall be readily retrievable.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(E) Prior to making an initial sale of dialysis solutions to a patient, a terminal distributor of dangerous drugs must have an order issued by a prescriber.

(1) The order must include the full name and address of the patient, the signature of the prescriber, the manually printed, typewritten, electronically generated or preprinted full name and address of the prescriber, the telephone number where the prescriber can be personally contacted during normal business hours, the date of issuance and the complete and accurate identification of each such product to be provided to the patient.

(2) The prescriber's order may be transmitted electronically to the retail seller.

(3) All orders issued in accordance with this paragraph are valid for a period of one year from the date of issuance.

(F) A terminal distributor of dangerous drugs shall report the theft or significant loss of dialysis solution pursuant to rule 4729:5-3-02 of the Administrative Code.

Last updated May 1, 2025 at 7:56 AM

History

Effective: May 1, 2025
Promulgated Under: 119.03

Chapter 4729:5-18 Remote Dispensing Pharmacies

Ohio Adm.Code 4729:5-18-01 Definitions - remote dispensing pharmacies.

As used in Chapter 4729:5-18 of the Administrative Code:

(A) "Remote dispensing pharmacy" means a pharmacy where the dispensing of drugs, patient counseling, and other pharmacist care is provided through a telepharmacy system. The dispensing of drugs at a remote dispensing pharmacy may include the dispensing of drug therapy-related devices.

(B) "Telepharmacy system" means a system that monitors the dispensing of drugs and provides for related drug utilization review and patient counseling services by an electronic method that complies with the requirements of rule 4729:5-18-06 of the Administrative Code. The telepharmacy system shall include the following technologies:

(1) Audio and video;

(2) Still image capture; and

(3) Store and forward.

(C) "Surveillance system" means a system providing continuous video footage of the remote dispensing pharmacy that is recorded and stored for at least sixty days and complies with the requirements of rule 4729:5-18-07 of the Administrative Code.

(D) "Supervising pharmacy" means a pharmacy licensed as a terminal distributor of dangerous drugs that exclusively oversees the operations of a remote dispensing pharmacy.

(E) "Supervising pharmacist" means a pharmacist holding a current Ohio license to practice pharmacy who has met the requirements to supervise a remote dispensing pharmacy as described in this chapter.

(F) "Responsible person" means the same as in rule 4729:5-2-01 of the Administrative Code.

(G) "Social vulnerability" means the demographic and socioeconomic factors that contribute to communities being more adversely affected by external hazards and stressors that cause disease and injury.

(H) "Social vulnerability index" or "SVI" means a risk score assigned to communities using U.S. census data. These data are grouped into four themes that cover four major areas of social vulnerability (household characteristics, house type and transportation, racial and ethnic minority status, and socioeconomic status) and then combined into a single measure of overall social vulnerability. The overall SVI score ranges from zero (least vulnerable) to one (most vulnerable).

Last updated April 7, 2026 at 7:52 AM

History

Effective: April 6, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-18-02 Licensure of remote dispensing pharmacies.

(A) A remote dispensing pharmacy shall apply for and obtain a terminal distributor of dangerous drugs license with a remote dispensing classification.

(B) The remote dispensing pharmacy shall comply with the licensing requirements of Chapter 4729:5-2 of the Administrative Code.

(C) Remote dispensing pharmacies shall have a pharmacist designated as the responsible person in accordance with rule 4729:5-2-01 of the Administrative Code.

(D) The responsible person designated for a remote dispensing pharmacy shall be the same responsible person designated for the supervising pharmacy. The responsible person may, but is not required to, act as a supervising pharmacist.

(E) If the supervising pharmacy and remote dispensing pharmacy are not under common ownership and control, the supervising pharmacy and remote dispensing pharmacy shall enter into a contract that specifies the services to be provided and the responsibilities and accountabilities of each party to the contract or agreement in compliance with federal and state statutes, rules, and regulations. The contract shall be maintained in a readily retrievable format.

Last updated April 7, 2026 at 7:50 AM

History

Effective: April 6, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-18-03 Demonstration of need.

(A) Except as provided in this rule, a remote dispensing pharmacy shall not be located within a ten-mile radius of a pharmacy that serves the public as an outpatient pharmacy as defined in Chapter 4729:5-5 of the Administrative Code.

(B) A remote dispensing pharmacy may be located within the ten-mile radius of an outpatient pharmacy if either of the following apply:

(1) The remote dispensing pharmacy is part of a federally qualified health center or federally qualified health center look-alike, as defined in section 3701.047 of the Revised Code, and the remote dispensing pharmacy is located on the same property as, or on a campus contiguous to, the health center or look-alike.

(2) The board approves a request, based on a demonstration of need, that meets the standards established in paragraph (C) of this rule.

(C) A person may submit a request to the board, in a manner determined by board, to allow a remote dispensing pharmacy located within a ten-mile radius of an outpatient pharmacy if the proposed remote dispensing pharmacy is located in census block that is medium-high (0.5-0.75) or high (greater than 0.75) based upon the social vulnerability index (SVI) as designated by the board's Ohio pharmacy access dashboard (accessible via www.pharmacy.ohio.gov).

(D) Persons may register to receive notice from the board (accessible via www.pharmacy.ohio.gov) of requests received pursuant to paragraph (C) of this rule. The board shall notify any person who has registered to be notified and allow for the submission of public comments on the proposed request.

(E) During the sixty-day period that begins on the date that the board sends the electronic notice, a pharmacy currently operating in the state may submit a request to the board for approval to operate a remote dispensing pharmacy.

(F) At the board's next regularly scheduled meeting that occurs on or after the date that is ninety days after the electronic notices are sent, the board shall review all the requests received and make its determination of whether any should be approved. As part of the board's determination, it shall consider the following:

(1) Any comments received from the public;

(2) The geographic proximity of the supervising pharmacy to the proposed remote dispensing pharmacy;

(3) The supervising pharmacy has not been disciplined for a violation of rule 4729:5-5-02 of the Administrative Code and all subsequent rules thereunder within the preceding twelve months;

(4) The supervising pharmacy has not been disciplined for any theft or significant loss of dangerous drugs within the preceding twelve months; and

(5) The supervising pharmacy is not currently on probation or has other restrictions placed upon its terminal distributor of dangerous drugs license pursuant to a settlement agreement or order of the board.

Last updated April 7, 2026 at 7:52 AM

History

Effective: April 6, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-18-04 Operation of a remote dispensing pharmacy.

(A) A remote dispensing pharmacy shall be located within this state in a building that is zoned for commercial or industrial use. A remote dispensing pharmacy shall not operate out of a personal residence.

(B) Remote dispensing pharmacies shall display a sign at the point of sale indicating that the facility is a remote dispensing pharmacy under continuous video surveillance and that the video is recorded and retained.

(C) The supervising pharmacy shall be exclusively responsible for the operation of a remote dispensing pharmacy and its employees.

(D) There shall be one supervising pharmacist at all times when the remote dispensing pharmacy is operational. The supervising pharmacist shall be located in this state when serving as a supervising pharmacist.

(E) The supervising pharmacist shall not be located more than fifty miles from a remote dispensing pharmacy under the pharmacist's supervision.

(F) To avoid disruption in pharmacy services, the supervising pharmacy shall have a process in place to ensure there is a pharmacist who meets the training requirements of this chapter if the regularly scheduled supervising pharmacist is unable to provide supervision.

(G) The remote dispensing pharmacy shall be physically staffed by at least two certified pharmacy technicians and/or pharmacy interns for the pharmacy to be open to the public.

(H) Unless a pharmacist is located on-site, there shall be no more than a total of three certified pharmacy technicians and/or pharmacy interns working within a remote dispensing pharmacy.

(I) Unless approved by the board, a supervising pharmacist shall not simultaneously oversee the activities of more than one remote dispensing pharmacy. The board may consider expanding this limit to two remote dispensing pharmacies per one supervising pharmacist. For the board to consider a waiver of this limitation, the supervising pharmacy shall submit documentation, in a manner determined by the board, that sufficiently demonstrates the following:

(1) The prescription volume and workload at the supervising pharmacy allows the supervising pharmacist to safely and effectively oversee more than one remote dispensing pharmacy;

(2) The prescription volume and workload at the remote dispensing pharmacies allows the supervising pharmacist to safely and effectively oversee more than one remote dispensing pharmacy; and

(3) Failure to grant this waiver may negatively impact patient health and access to pharmacy services.

(J) Certified pharmacy technicians, pharmacy interns, and pharmacists shall complete a training program to ensure that the telepharmacy system can be operated in a safe and effective manner. Training documentation shall be maintained at, or accessible by, the remote dispensing pharmacy and be produced for review immediately upon request of agent, officer, or inspector of the board. Remote dispensing pharmacies shall conduct additional training for their employees if any of the following occurs:

(1) The telepharmacy system used by the remote dispensing pharmacy has changed;

(2) The existing telepharmacy system used by the remote dispensing pharmacy has undergone significant updates.

(K) Unless approved by the board, a remote dispensing pharmacy shall not dispense more than an average of one hundred fifty prescriptions per day during a ninety-day period. For the board to consider a waiver of this limitation, a remote dispensing pharmacy shall submit documentation, in a manner determined by the board, that sufficiently demonstrates the following:

(1) The remote dispensing pharmacy is located in a census block that is medium-high (0.5-0.75) or high (greater than 0.75) based upon the social vulnerability index (SVI) as designated by the board's Ohio pharmacy access dashboard (accessible via www.pharmacy.ohio.gov); and

(2) It is not economically feasible for the remote dispensing pharmacy to convert to an outpatient pharmacy as defined by Chapter 4729:5-5 of the Administrative Code.

(L) The responsible person shall perform on-site visits of the remote dispensing pharmacy at least once per quarter. The on-site visit shall be documented by the responsible person and such documentation shall be immediately retrievable at the location licensed as a remote dispensing pharmacy for three years from the date of the visit by the responsible person. As part of this site visit, the responsible person shall conduct a controlled substance inventory in accordance with rule 4729:5-3-07 of the Administrative Code.

(M) In the event that the telepharmacy system is not in operation, the supervising pharmacist shall be physically located on-site to dispense prescriptions.

(N) A remote dispensing pharmacy shall implement a continuous quality improvement program in accordance with rule 4729:5-3-22 of the Administrative Code.

(O) A remote dispensing pharmacy shall comply with all applicable requirements for the operation of an outpatient pharmacy in accordance with Chapter 4729:5-5 of the Administrative Code.

(P) A remote dispensing pharmacy that holds a category III terminal distributor of dangerous drugs license shall maintain a perpetual controlled substance inventory for all controlled substances stocked by the remote dispensing pharmacy. The inventory shall be established in a manner that will provide total accountability in all aspects of controlled substance distribution.

Last updated April 7, 2026 at 7:52 AM

History

Effective: April 6, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-18-05 Personnel requirements.

(A) The supervising pharmacy is solely responsible for ensuring that the requirements of this rule are met.

(B) Before a pharmacist may act as the supervising pharmacist for a remote dispensing pharmacy, a pharmacist shall:

(1) Be licensed as a pharmacist under Chapter 4729. of the Revised Code;

(2) Be physically located in this state when acting as the supervising pharmacist; and

(3) Be employed by or under contract with the supervising pharmacy.

(1) Supervise no more than three certified pharmacy technicians and/or pharmacy interns per remote dispensing pharmacy.

(2) Be in full and actual charge of the remote dispensing pharmacy by using the pharmacy's telepharmacy and surveillance system.

(3) Through the telepharmacy system and surveillance system, oversee the pharmacy interns and/or certified pharmacy technicians who are staffing the remote dispensing pharmacy.

(4) Verify each prescription and drug dispensed pursuant to the prescription and provide verification through visual review, barcoding, and any other technology as specified in rule 4729:5-18-06 of the Administrative Code.

(a) All barcodes used shall be scanned, and not manually typed, into the system.

(b) Documentation of verification shall capture the positive identification of the supervising pharmacist.

(5) Offer to provide the service of counseling for each drug dispensed pursuant to a new or refill prescription in accordance with rule 4729:5-5-09 of the Administrative Code.

(6) Have completed a training program on the proper use of the telepharmacy system used at the remote dispensing pharmacy.

(7) Have completed a training program on the proper use of the surveillance system used at the remote dispensing pharmacy.

(D) Before a certified pharmacy technician may work in a remote dispensing pharmacy, the certified pharmacy technician shall:

(1) Hold an active registration as a certified pharmacy technician under Chapter 4729. of the Revised Code;

(2) Hold a national certification as a pharmacy technician from an organization recognized by the board as defined in rule 4729:3-1-01 of the Administrative Code.

(3) Have completed a training program on the proper use of the telepharmacy system used at the remote dispensing pharmacy.

(4) Have at least one thousand hours of practical experience working as a certified pharmacy technician in a pharmacy setting under the direct supervision of a pharmacist.

(5) Have worked at least one year in a pharmacy setting during the three years preceding the date the certified pharmacy technician begins working at the remote dispensing pharmacy.

(E) The supervising pharmacy shall attest that all certified pharmacy technicians meet the requirements of paragraph (D) of this rule. A record of such attestation shall be maintained at, or accessible by, the remote dispensing pharmacy and be produced for review immediately upon request of agent, officer, or inspector of the board.

(F) Before a pharmacy intern may work in a remote dispensing pharmacy, the pharmacy intern shall:

(1) Hold an active license as a pharmacy intern under Chapter 4729. of the Revised Code;

(2) Have at least one thousand hours of experience working as a certified pharmacy technician or pharmacy intern under the direct supervision of a pharmacist;

(3) Only five hundred hours of experience earned as part of the intern's introductory pharmacy practice experience or advanced pharmacy practice experience may count towards the hourly requirements described in paragraph (F)(2) of this rule.

(4) Have worked at least one thousand hours in a pharmacy setting during the three years preceding the date the pharmacy intern begins working at the remote dispensing pharmacy;

(5) Have completed a training program on the proper use of the telepharmacy system used at the remote dispensing pharmacy.

(G) The supervising pharmacy shall attest that all working pharmacy interns meet the requirements of paragraph (F) of this rule. A record of such attestation shall be maintained at, or accessible by, the remote dispensing pharmacy and be produced for review immediately upon request of agent, officer, or inspector of the board.

(H) Certified pharmacy technicians or pharmacy interns are not permitted to do any of the following while working at a remote dispensing pharmacy:

(1) Counsel an individual regarding drugs that are dispensed, recommend drugs and drug therapy-related devices or otherwise provide advice regarding drug therapy, or assist with selecting drugs and drug therapy related devices for treatment of common diseases and injuries or assist with providing instruction on their use;

(2) Perform compounding of sterile or nonsterile drugs, except for the reconstitution of prepackaged dangerous drugs;

(3) Engage in the repackaging of dangerous drugs;

(4) Administer immunizations or perform diagnostic testing, unless a pharmacist is physically onsite to provide direct supervision.

(I) Technicians-in-training, registered pharmacy technicians, or any other pharmacy personnel who do not meet the requirements of this chapter shall not engage in the practice of pharmacy or work at a remote dispensing pharmacy.

Last updated April 7, 2026 at 7:50 AM

History

Effective: April 6, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-18-06 Technology requirements for a telepharmacy system.

(A) There shall be a fully functioning telepharmacy system in the remote dispensing pharmacy. The system shall always be operational when pharmacy personnel are working in the pharmacy.

(1) The telepharmacy system shall utilize positive identification and comply with the record keeping requirements for outpatient pharmacies in accordance with Chapter 4729:5-5 of the Administrative Code.

(2) In the event that the telepharmacy system is not functional for more than one-business day, the supervising pharmacist or another pharmacist employed by the supervising pharmacy shall be required to be physically on-site to allow for prescriptions to be dispensed during the normal business hours of the remote dispensing pharmacy.

(3) The supervising pharmacy shall have backup procedures to ensure prescriptions may be dispensed in the event of a telepharmacy system outage that is greater than one business day.

(4) In the event of a temporary telepharmacy system outage of less than the duration of one business day, the supervising pharmacist may direct the certified pharmacy technicians and/or pharmacy interns at the remote dispensing pharmacy to complete activities not requiring pharmacist verification or use of the telepharmacy system. Staff at the remote dispensing pharmacy may continue to sell prescriptions that have already been verified and dispensed by the pharmacist. In this case, patients shall be provided with a phone number where they can obtain patient counseling in accordance with rule 4729:5-5-09 of the Administrative Code.

(5) The telepharmacy system shall comply with all the following:

(a) Chapter 3798. of the Revised Code;

(b) 42 U.S.C. 1320d et. seq. (9/5/2025); and

(B) The telepharmacy system shall, at a minimum, have high-definition image resolution with variable viewing options to accurately and safely dispense a dangerous drug or drug device and sufficient data retention capabilities to investigate any quality-related events.

(1) The telepharmacy system must produce images that are high definition with image resolution of at least three hundred pixels per inch.

(2) The images shall contain the following to ensure the pharmacist is able to appropriately verify the prescription prior to dispensing.

(a) A clear image of the prescription label affixed to the medication or device;

(b) The full quantity of the filled prescription;

(c) Except as provided in paragraph (B)(3) of this rule, the medication stock bottle or container and label of a drug that has been returned to stock in accordance with rule 4729:5-5-22 of the Administrative Code used to fill the prescription, if applicable; and

(d) Clear markings present on the pill or capsule, if applicable.

(3) The board may waive or modify the requirements listed in paragraph (B)(2)(c) of this rule if the remote dispensing pharmacy can provide an alternative method that accurately captures information from the medication stock bottle and/or container and label of a drug that has been returned to stock in accordance with rule 4729:5-5-22 of the Administrative Code.

(4) Images associated with the verification and dispensing of a prescription or device shall be retained and become part of the patient's profile and maintained for one year.

(C) There shall be a working computer link, video link, and audio link to the supervising pharmacist whenever the remote dispensing pharmacy is open to the public. The required technology must allow the supervising pharmacist to provide the personal assistance, direction, and approval needed to verify and ensure remote tasks are safely and properly performed.

(D) Written prescriptions presented to the remote dispensing pharmacy shall be scanned into the telepharmacy system. The original prescription must be able to be viewed at both the remote dispensing pharmacy and the supervising pharmacy.

(1) All information in the prescription shall be scanned in full color (i.e., retains color information and/or color graphics in the document) via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user.

(2) A prescription record or image once created shall be unalterable but may be annotated as necessary so long as the original record or image is still available for review and the individual that made the annotation is noted.

(E) Certified pharmacy technicians and/or pharmacy interns shall use barcoding technology when filling prescriptions at a remote dispensing pharmacy to ensure the accuracy of prescriptions dispensed in accordance with this chapter. Barcodes shall be scanned, and not manually typed, into the system.

The board may waive or modify the barcode technology requirements listed in this paragraph if the remote dispensing pharmacy can provide an alternative method to ensure the accuracy of prescriptions dispensed in accordance with this chapter.

(F) All records of prescriptions dispensed, including the records of the actions performed through the telepharmacy system, shall be maintained at the remote dispensing pharmacy, in a readily retrievable manner, for three years after the dispensation of the prescription.

Last updated April 7, 2026 at 7:53 AM

History

Effective: April 6, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-18-07 Security requirements for a remote dispensing pharmacy.

(A) There shall be a fully functioning surveillance system in the remote dispensing pharmacy that is operational at all times.

(1) No operations of the remote dispensing pharmacy shall commence if the surveillance system is not functional.

(2) The video produced by the surveillance system must be stored for sixty days in a readily retrievable manner.

(3) The surveillance system shall be capable of providing not less than four simultaneous camera views of the pharmacy operation at the remote dispensing pharmacy.

(B) The surveillance system must allow the supervising pharmacist to determine who has accessed the pharmacy. A supervising pharmacist shall complete a training program on proper use of the surveillance system and documentation of this completion must be maintained at, or accessible by, the remote dispensing pharmacy and be produced for review immediately upon request of agent, officer, or inspector of the board.

(C) The supervising pharmacist shall supervise the remote dispensing pharmacy via the pharmacy surveillance system to deter and detect theft or diversion.

(D) The supervising pharmacist shall ensure that all dangerous drugs, drug devices, controlled substances, and hypodermics that are delivered onto the premises of the remote dispensing pharmacy are immediately placed and secured in the pharmacy.

(E) Pharmacy technicians and pharmacy interns who meet the qualifications of rule 4729:5- 18-05 of the Administrative Code and are employed by the remote dispensing pharmacy may only access the pharmacy if the supervising pharmacist is providing supervision via the pharmacy's surveillance system.

(F) An unlicensed person is permitted to enter the remote dispensing pharmacy if all the following apply:

(1) The person is performing maintenance or repair of the pharmacy;

(2) The supervising pharmacist provides supervision of the unlicensed person via the pharmacy's surveillance system; and

(3) There are two certified pharmacy technicians or pharmacy interns present in the pharmacy to provide on-site supervision of the unlicensed person.

(G) All schedule II controlled substance dangerous drugs shall be stored in a securely locked, substantially constructed cabinet or safe and shall not be dispersed throughout the stock of dangerous drugs maintained by the pharmacy. The cabinet or safe shall remain locked and secured when not in use. Schedule III through V controlled substance dangerous drugs may be stored with Schedule II controlled substance dangerous drugs.

(H) A remote dispensing pharmacy shall be secured by both:

(1) A physical barrier (i.e., barricade) with suitable locks approved by the board. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board, in a manner determined by the board, of any installation or modification to a physical barrier prior to implementation.

(2) An alarm system approved by the board that is monitored by a central station for control and can detect unauthorized access to the pharmacy. The alarm system shall be tested on a biannual basis. The pharmacy or the entity that manages security for the pharmacy shall maintain testing records for three years from the date of testing and shall make such records readily retrievable. The pharmacy shall be responsible for obtaining testing records if such records are maintained by a third-party. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board, in a manner determined by the board, of any installation or modification to an alarm system prior to implementation.

(I) The remote dispensing pharmacy shall contain all dangerous drugs, hypodermics, and D.E.A. controlled substance order forms and every other item or product that requires the supervision or sale by a pharmacist.

(J) Only the supervising pharmacist, certified pharmacy technicians, and pharmacy interns employed by the remote dispensing pharmacy may have access to keys or other methods of gaining access to the pharmacy.

(K) All keys, combinations, or access codes, including alarm codes, shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(L) No prescription, dangerous drug, hypodermic, nor any other item or product that requires the supervision or sale by a pharmacist may be sold, given away, or disposed of at any time the pharmacy is closed or the surveillance system is inoperable.

(M) New or refill prescriptions may be deposited into a secure area within the building where the pharmacy is located when the pharmacy is closed.

(N) If a remote dispensing pharmacy provides services by means of a drive-through facility, the drive-through facility shall be constructed and maintained in a manner, and with materials, that secures the premises of the pharmacy from unauthorized access.

Last updated April 7, 2026 at 7:51 AM

History

Effective: April 6, 2026
Promulgated Under: 119.03

Chapter 4729:5-19 Clinics and Prescriber Offices

Ohio Adm.Code 4729:5-19-01 Clinics and prescriber offices - definitions.

As used in Chapter 4729:5-19 of the Administrative Code:

(A) "Clinic" or "prescriber office" means a facility licensed as a terminal distributor of dangerous drugs in accordance with section 4729.54 of the Revised Code where a licensed prescriber, as specified in rule 4729:5-2-01 of the Administrative Code, or pharmacist serves as the responsible person on the license and drugs are possessed on-site for administration or to personally furnish. The facility shall comply with all requirements set forth in this chapter. A clinic or prescriber office does not include a veterinary clinic as defined in rule 4729:5-20-01 of the Administrative Code.

(B) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(D) "Dosage unit" means any of the following:

(1) A single pill, capsule, ampule, or tablet;

(2) In the case of a liquid solution, one milliliter;

(3) In the case of a cream, lotion, or gel, one gram; or

(4) Any other form of administration available as a single unit.

(E) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as in rule 4729:5-1-02 of the Administrative Code but shall be limited to a prescriber practicing within the prescriber's applicable scope of practice.

(F) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(H)

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier.

(I) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer, or inspector of the board.

(J) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

(K) "Sample" means a dangerous drug or pharmaceutical preparation that would be hazardous to health or safety if used without the supervision of a licensed health professional authorized to prescribe drugs, or a drug of abuse, and that, at one time, had been placed in a container plainly marked as a sample by a manufacturer.

Last updated April 1, 2026 at 8:34 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-19-02 Personally furnishing dangerous drugs.

(A) A prescriber who personally furnishes a dangerous drug, other than a sample drug pursuant to section 3719.81 of the Revised Code, shall affix to the container a label showing:

(1) The name and address of the prescriber;

(2) The name of the patient for whom the drug is intended;

(3) Name and strength of the drug;

(4) Directions for use;

(5) Date furnished; and

(6) If a compounded drug, the statement "Compounded Drug" or other similar statement shall also be displayed prominently on the label.

(B) A prescriber who personally furnishes a dangerous drug labeled as a sample and where the directions for use are different from the directions on or in the sample container shall affix a label to the sample container or provide written documentation accompanying the sample that includes the following:

(1) The name of the prescriber;

(2) The name of the patient for whom the drug is intended; and

(3) Directions for use.

(C) For controlled substances, quantities personally furnished to a patient are limited to a seventy-two-hour supply and quantities personally furnished to all patients shall not exceed two thousand five hundred dosage units in any thirty day period pursuant to section 4729.291 of the Revised Code.

(D) None of the following shall be counted in determining whether the amounts specified in paragraph (C) of this rule have been exceeded:

(1) Methadone personally furnished to patients for the purpose of treating drug dependence or addiction, if the prescriber meets the conditions specified in 21 C.F.R. 1306.07 (8/8/2023).

(2) Buprenorphine personally furnished to patients for the purpose of treating drug dependence or addiction as part of an opioid treatment program licensed under section 5119.37 of the Revised Code.

(3) Controlled substances personally furnished to research subjects by a facility conducting clinical research in studies approved by a hospital-based institutional review board or an institutional review board accredited by the association for the accreditation of human research protection programs.

(E)

(1) Except as provided in paragraph (E)(2) of this rule, only a prescriber shall personally furnish a drug. The act of personally furnishing shall be documented using positive identification.

(2) A prescriber may delegate the act of personally furnishing to a licensed Ohio pharmacist practicing at a free clinic, as defined in section 3701.071 of the Revised Code. The act of personally furnishing shall be documented using positive identification.

(F)

(1) A prescriber may designate a licensed health care professional acting within the scope of the professional's practice and, under the personal supervision of a prescriber or pharmacist, to prepare and package a dangerous drug that will be personally furnished by the prescriber or a pharmacist in accordance with paragraph (E)(2) of this rule.

(2) A prescriber may designate an unlicensed person, under the personal supervision of a prescriber or pharmacist, to prepare and package a dangerous drug that will be personally furnished by the prescriber or a pharmacist in accordance with paragraph (E)(2) of this rule. An unlicensed person shall not prepare and package controlled substances.

(3) Pursuant to rule 4729:7-3-04 of the Administrative Code, a prescriber shall not personally furnish immediate-use compounded drug preparations.

(G) Counseling.

(1) A prescriber, pharmacist, or a delegate in accordance with paragraph (H)(1) of this rule shall personally offer to provide, or may provide in writing, the service of counseling pursuant to paragraph (G)(2) of this rule to a patient or caregiver whenever any dangerous drug is personally furnished. A prescriber or pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses, either verbally or in writing, the offer of counseling or does not respond to the written offer to counsel.

(2) Prescriber or pharmacist counseling may include, but is not limited to, the following:

(a) The name and description of the drug;

(b) The dosage form, dose, route of administration, and duration of drug therapy;

(d) Special directions and precautions for preparation, administration, and use by the patient;

(e) Common adverse effects or interactions and therapeutic contraindications that may occur, including possible methods to avoid them, and the action required if they occur;

(f) Techniques for self-monitoring drug therapy;

(g) Proper storage and disposal;

(h) Action to be taken in the event of a missed dose; and

(i) The prescriber or pharmacist's comments relevant to the patient's drug therapy, including other necessary information unique to the specific patient or drug.

(H) Provision of dangerous drugs.

(1) A prescriber may delegate an individual or individuals to distribute dangerous drugs personally furnished by a prescriber or pharmacist if all the following apply:

(a) A prescriber or pharmacist provides personal supervision;

(b) Counseling is offered in accordance with paragraph (G) of this rule; and

(2) Paragraph (H)(1)(a) of this rule does not apply if a non-controlled substance dangerous drug is provided to the patient by a licensed health care professional, acting within the scope of the professional's practice, and a prescriber or pharmacist is available for counseling by means of electronic communication during normal hours of operation.

(I) No prescriber or pharmacist acting in accordance with paragraph (E)(2) of this rule may personally furnish to a patient to whom there is no valid prescriber patient relationship, pursuant to applicable state and federal laws, regulations, and rules.

(J) Naloxone and other overdose reversal drugs may be personally furnished or otherwise distributed in accordance with Chapter 3715. of the Revised Code. A terminal distributor of dangerous drugs shall not be required to maintain any patient-specific records for the distribution of naloxone or other overdose reversal drug.

(K) Any patient specific dangerous drug dispensed by a pharmacy that is provided to a patient by a prescriber pursuant to rule 4729:5-3-24 of the Administrative Code is the property of that patient and is not considered personally furnishing. No prescriber that provides a patient with a drug pursuant to rule 4729:5-3-24 of the Administrative Code shall charge any additional fees or require any additional monetary compensation for the dangerous drug.

(L) Paragraph (K) of this rule does not prohibit a prescriber from charging a patient for any of the following:

(1) The cost of an office visit or any expense related to the administration of a dangerous drug; or

(2) The cost of a dangerous drug dispensed by a pharmacy to a patient if paid for by the prescriber.

(M) A prescriber personally furnishing dangerous drugs shall comply with all drug database reporting requirements pursuant to Chapter 4729. of the Revised Code and division 4729:8 of the Administrative Code.

(N) Except as provided in paragraph (O) of this rule, a prescriber may only mail or provide delivery of a dangerous drug that has been personally furnished if all the following apply:

(1) The prescriber does not routinely mail or deliver the drug to the patient;

(2) The drug is unavailable at a local pharmacy or the patient cannot afford the drug;

(3) Failure to mail or deliver the drug would result in harm to the patient; and

(4) The prescriber includes in the records required for personally furnishing the name of the common carrier (including the United State postal service), contract carrier, or employee of the terminal distributor who performed, or attempted to perform, the delivery.

(O) The restrictions listed of paragraph (N) of this rule do not apply if the drug that has been personally furnished is either:

(1) Part of a clinical trial approved by the United States food and drug administration. A prescriber that mails or delivers a drug that is part of a clinical trial shall comply with the requirements of paragraph (N)(4) of this rule; or

(2) Delivered or otherwise provided by a mobile clinic or medication unit in accordance with rule 4729:5-3-23 of the Administrative Code.

(P) Any drug that has left the possession of the terminal distributor of dangerous drugs shall comply with the requirements of rule 4729:5-3-16 of the Administrative Code.

Last updated April 1, 2026 at 8:34 AM

History

Effective: April 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-19-03 Security, control and storage of dangerous drugs.