Ohio Adm.Code 4729:6 | Ohio Administrative Code 4729:6 — State Board of Pharmacy | Distributors of Dangerous Drugs

Chapter 4729:6-1 Definitions

Ohio Adm.Code 4729:6-1-01 Definitions - distributors of dangerous drugs.

As used in this division:

(A) "Distributor of dangerous drugs" or "drug distributor" means the following persons licensed in accordance with section 4729.52 of the Revised 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.

(B) "Abandoned application" means an application submitted for licensure in accordance with this division that meets the criteria 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 demonstrate compliance with rule 4729:6-2-01 of the Administrative Code and the applicable licensing rules pursuant to this division within ninety days of receipt of a completed application. The applicant may submit a request to the executive director or the director's designee for a one-time, ninety-day extension.

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

(c) An applicant 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, information technology or other staff that may need limited supervised access to areas where dangerous drugs or drug enforcement administration controlled substance order forms are stored.

(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) "Broker" means any person engaged in the marketing, offering, or contracting for wholesale distribution and sale of dangerous drugs in or into Ohio who does not take physical possession of the dangerous drugs. A broker shall be licensed as a wholesale distributor pursuant to section 4729.52 of the Revised Code with a broker classification.

(H) "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.

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

(J) "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.

(K) "Manufacturer of dangerous drugs" or "manufacturer" means a person, other than a pharmacist or prescriber, that meets the following criteria:

(1) Meets the definition of a manufacturer pursuant in section 21 U.S. Code Section 360 eee (11/27/2013); and

(2) Manufactures dangerous drugs and who is engaged in the sale or distribution of dangerous drugs in or into Ohio.

(L) "Outsourcing facility" means a facility that is engaged in the compounding and sale of sterile drugs and is registered as an outsourcing facility with the United States food and drug administration.

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

(N) "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.

(O)

(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:

(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 of positive identification 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.

(P) "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.

(Q) "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.

(R) "Repackager of dangerous drugs" or "repackager" means a person that meets the following:

(1) Repacks and relabels dangerous drugs for sale or distribution; and

(2) Is required to register with the United States food and drug administration to engage in the repackaging or relabeling of dangerous drugs.

(S) "Reverse distribute" or "reverse distribution" means to acquire dangerous drugs for the purpose of any of the following:

(1) Return to a manufacturer or entity authorized by the manufacturer to accept returns on the manufacturer's behalf; or

(2) Destruction or disposal.

(T) "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.

(U) "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.

The shipment of dangerous drugs to a reverse distributor in this state licensed as a wholesale distributor of dangerous drugs in accordance with section 4729.52 of the Revised Code for the sole purpose of destruction or disposal of dangerous drugs, does not constitute a sale and does not require the person, if located outside of the state of Ohio, shipping the dangerous drugs to the reverse distributor to possess an Ohio license in accordance with Chapter 4729. of the Revised Code.

(V) "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.

(W) "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.

(X) "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 4729.561 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.

(Y) "Third-party logistics provider" means a person that provides or coordinates warehousing or other logistics services pertaining to dangerous drugs including distribution, on behalf of a manufacturer, wholesale distributor, or terminal distributor of dangerous drugs, but does not take ownership of the drugs or have responsibility to direct the sale or disposition of the drugs.

(Z) "Virtual wholesaler" or "virtual wholesaler distributor" means any person engaged in wholesale distribution of dangerous drugs in or into Ohio who has title but does not take physical possession of the dangerous drugs. A virtual wholesale distributor shall be licensed as a wholesale distributor pursuant to section 4729.52 of the Revised Code with a virtual wholesale distributor classification.

(AA) "Wholesale distributor of dangerous drugs" or "wholesale distributor" means a person engaged in the sale of dangerous drugs at wholesale or the reverse distribution of dangerous drugs and includes any agent or employee of such a person authorized by the person to engage in the sale of dangerous drugs at wholesale.

(BB) "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 July 1, 2026 at 12:26 PM

History

Effective: September 30, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-2-01

(A) A location licensed as a distributor of dangerous drugs, in accordance with section 4729.52 of the Revised Code, shall have a responsible person at all times.

(B) When there is a change of responsible person, the state board of pharmacy shall be notified by the new responsible person within ten days of the effective date of the appointment of the new responsible person in a manner determined by the board. The new responsible person shall submit to a criminal records check in accordance with rule 4729:6-2-03 of the Administrative Code.

(C) For all category III drug distributor licenses, a complete inventory, pursuant to rule 4729:6-3-06 of the Administrative Code shall be taken of the controlled substances on site by the new responsible person no later than thirty days from the separation date of the responsible person. The new responsible person shall be responsible for completing and maintaining this inventory record at the location licensed as a drug distributor.

(D) The responsible person for a location licensed as a distributor of dangerous drugs shall be responsible for compliance with all applicable state and federal laws, regulations, and rules governing the manufacture, sale and distribution of dangerous drugs.

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

(F) The board of pharmacy shall issue a resolution providing the credential types or qualifications required for the responsible person of each license/classification/business type of a distributor of dangerous drugs licensed in accordance with section 4729.52 of the Revised Code. Only individuals that meet the credentials specified may be the responsible person for that license/classification/business type. The resolution shall be updated as necessary and made available on the board's web site, www.pharmacy.ohio.gov.

(G) Unless otherwise approved by the board, a drug 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 agency as part of an official order of that 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 disciplined by the state board of pharmacy pursuant to Chapter 4729. of the Revised Code, except for a disciplinary action related to the failure to timely obtain continuing education required pursuant to agency 4729 of the Administrative Code.

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

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

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

(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.

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

Last updated April 25, 2022 at 8:30 AM

History

Effective: April 25, 2022
Promulgated Under: 119.03

Chapter 4729:6-2 Licensure

Ohio Adm.Code 4729:6-2-01 Responsible person - drug distributor.

(A) A location licensed as a distributor of dangerous drugs, in accordance with section 4729.52 of the Revised Code, shall have a responsible person at all times.

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

(G) Unless otherwise approved by the board, a drug 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 agency as part of an official order of that 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.

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

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

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

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

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

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

Last updated April 25, 2022 at 8:30 AM

History

Effective: April 25, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-2-03

(A) Unless otherwise approved by the board, a new distributor of dangerous drug license will not be issued until the following persons submit fingerprints to the Ohio bureau of criminal investigation (BCI) for a criminal records check in accordance with paragraph (C) of this rule:

(1) The responsible person on the application for licensure; and

(2) The following persons based upon the drug distributor's business type:

(a) All partners of a partnership.

(b) The sole proprietor of a sole proprietorship.

(i) If the limited liability company has a member which is not a natural person, the limited liability company's president, vice president, secretary, treasurer, and chief executive officer, or any equivalent position.

(ii) If the limited liability company's sole member is a publicly traded corporation, the limited-liability company may seek a waiver pursuant to paragraph (A)(3) of this rule.

(d) Except as provided in paragraph (A)(3) of this rule, the president, vice president, secretary, treasurer, and chief executive officer, or any equivalent position of a corporation and, if a corporation is not publicly traded on a major stock exchange, each shareholder owning ten percent or more of the voting stock of the corporation. If the director or the director's designee determines other person(s) in the organizational structure have substantial control, such as the power to influence management and operational decision-making over the distribution of dangerous drugs, the director or designee may require a criminal records check of those with substantial control in addition to or in place of those persons set forth in this paragraph.

(e) The executive director or any equivalent position of a nonprofit organization.

(3) For publicly traded corporations, the board's executive director or the director's designee may waive the criminal records checks required in paragraph (A)(2)(c) of this rule under the following circumstances:

(a) The publicly traded corporation submits a request to the executive director and includes the organizational structure of the corporation, including all corporate officer positions responsible for directing the distribution of dangerous drugs. The director or the director's designee may request additional information about the corporation's organizational structure.

(b) The executive director or the director's designee approves an alternate list of corporate officers who are required to submit a criminal records check. If approval is not provided, the publicly traded corporation shall comply with paragraph (A)(2)(c) of this rule.

(B) The persons listed in paragraph (A)(2) of this rule shall be a natural person that owns and/or operates the business entity applying for licensure. In the event the applicant is not owned by a natural person, each business entity with an ownership interest in the applicant must be disclosed on the application up to and through the entity that is owned by a natural person, who shall be subject to a criminal records check in accordance with this rule.

(C) All criminal records checks conducted in accordance with this rule shall consist of both a BCI criminal records check and a federal bureau of investigations records check (FBI) and shall comply with the following:

(1) Be based on electronic fingerprint impressions that are submitted directly to BCI from a WebCheck provider agency or ink impressions. The state board of pharmacy may accept the results of a criminal records check based on ink impressions only in the following circumstances:

(a) Readable electronic fingerprint impressions cannot be obtained or are rejected by either BCI or FBI;

(b) The person or persons listed in paragraph (A) of this rule reside outside of the state of Ohio; or

(c) The person or persons listed in paragraph (A) of this rule have a home address that is seventy-five miles or more from the nearest WebCheck location.

(2) Results will only be considered valid if the fingerprint impressions were obtained within one year of the date the application is received by the board.

(3) The results of the criminal records check must be sent directly to the state board of pharmacy from BCI.

(D) Only new persons listed in paragraphs (A)(1) and (A)(2) of this rule shall be required to submit to a criminal records check for a new application resulting from a change in the description of a distributor of dangerous drugs pursuant to rule 4729:6-2-05 of the Administrative Code.

Last updated September 3, 2024 at 8:36 AM

History

Effective: August 31, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-06

(A) All category III drug distributor licenses shall complete a controlled substances inventory in accordance with 21 CFR 1304.11 (9/9/2014).

(B) The drug distributor's responsible person shall be responsible for completing and maintaining this inventory record.

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

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

Last updated September 3, 2024 at 8:38 AM

History

Effective: August 31, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-2-02 Distributor of dangerous drugs licensing and renewal.

(A) All drug distributor licenses issued pursuant to Chapter 4729. of the Revised Code shall expire on the thirtieth day of June of every odd-numbered year. A license shall be renewed biennially according to the provisions of sections 4729.52 and 4729.53 of the Revised Code and the standard renewal procedure of Chapter 4745. of the Revised Code.

(B) An initial drug distributor license issued on or after the first day of May of every odd-numbered year shall receive an expiration date of the thirtieth day of June of the next odd-numbered year.

(C) A drug distributor who seeks to renew a license shall submit an application for renewal and pay the required fee in accordance with section 4729.52 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 drug distributor who has experienced a change in responsible person pursuant to section 4729:6-2-01 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 drug distributor who has experienced a change in description pursuant to rule 4729:6-2-05 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 4729:6-2-05 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 distributor of dangerous drug license shall be in accordance with sections 4729.52 and 125.18 of the Revised Code.

(G) Licensure pursuant to section 4729.52 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 drug distributor licensed pursuant section 4729.52 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 drug distributor until a valid license is issued by the board.

(I) A drug distributor 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 4729.55 and 125.18 of the Revised Code.

(J) A drug distributor 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 section 4729.55 and 125.18 of the Revised Code. A drug distributor filing a reinstatement application must meet the requirements of this chapter and section 4729.52 of the Revised Code.

(K) Paragraphs (D) and (E) of this rule do not limit the board from taking disciplinary action pursuant to rule 4729:6-4-01 of the Administrative Code against a licensee for failure to comply with the requirements of Chapter 4729:6-2 of the Administrative Code.

Last updated March 7, 2024 at 1:00 PM

History

Effective: March 7, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-2-05

(A) Any change in the ownership, business or trade name, category, or address of a 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 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 drug 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) 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 9:00 AM

History

Effective: October 1, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-4-01

(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 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 4729.56 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 licensure or licensure renewal under section 4729.52 of the Revised Code.

(2) Violating any federal, state, or local drug law; any provision of Chapter 2925., 3715., 3719., or 4729. of the Revised Code; or any rule of the board.

(3) A conviction of a felony.

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

(5) Failing to satisfy the qualifications for licensure under section 4729.53 of the Revised Code or the rules of the board or ceasing to satisfy the qualifications after the license is granted or renewed.

(6) Falsely or fraudulently promoting to the public a drug that is a controlled substance included in schedule I, II, III, IV, or V, except that nothing in this rule prohibits a drug distributor from furnishing information concerning a controlled substance to a health care provider or licensed terminal distributor.

(7) Violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), United States Code Title 21 (10/22/2017).

(8) Failing to comply with the requirements of rule 4729:6-3-05 of the Administrative Code.

(9) Conducting the sale of a suspicious order without conducting an independent analysis prior to completing a sale to determine whether the reported drugs are likely to be diverted from legitimate channels in accordance with rule 4729:6-3-05 of the Administrative Code.

(10) Commission of a crime of moral turpitude as defined in section 4776.10 of the Revised Code.

(11) 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.

(12) Exclusion from participation in Medicare or a state health care program.

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

(14) 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.

(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 4729:6-2-01 of the Administrative Code.

(20) 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.

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

(22) 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 state or federal professional licensing or regulatory agency to a spouse or other family member.

(23) 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 state or federal professional licensing or regulatory 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.

(24) Unless otherwise approved by the board, a 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 disciplined by the state board of pharmacy pursuant to Chapter 4729. of the Revised Code, except for a disciplinary action related to the failure to timely obtain continuing education required pursuant to agency 4729 of the Administrative Code.

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

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

(k) 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.

(l) 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 12:26 PM

History

Effective: April 25, 2022
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-2-04 Drug distributor applications.

(A) The following information shall be required on a form supplied by the state board of pharmacy from each person making application for a license as a distributor of dangerous drugs:

(1) The name, full physical business address (not a post office box), and telephone number.

(2) All trade, fictitious, or business names used by the licensee (e.g. "doing business as" or "formerly known as").

(3) Addresses, telephone numbers, and the full names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of dangerous drugs located in this state or used to distribute drugs into this state.

(4) The type of ownership or operation (i.e., sole proprietorship, partnership, limited liability company, corporation, government agency, or nonprofit organization).

(5) The following information for the owner(s) and/or operator(s) of the drug distributor:

(a) For a partnership:

(i) The full name, business address, social security number, and date of birth of each partner. If the partner is not a natural person, each business entity that is a partner having an ownership interest must be disclosed on the application up to and through the entity that is owned by a natural person.

(ii) The name of the partnership.

(iii) The partnership's federal employer identification number.

(b) For a sole proprietorship: the full name, business address, social security number, and date of birth of the sole proprietor.

(c) For a limited lability company: the full name, business address, social security number, and date of birth of each member. If the member(s) is not a natural person, each business entity that is a member having an ownership interest must be disclosed on the application up to and through the entity that is owned by a natural person.

(d) For a corporation:

(i) The full name, business address, social security number, and date of birth of the corporation's president, vice-president, secretary, treasurer, and chief executive officer, or any equivalent position. For a publicly traded corporation that obtains a criminal records check waiver pursuant to paragraph (A)(3) of rule 4729:6-2-03 of the Administrative Code, the full name, business address, social security number, and date of birth of the corporate officers subject to a criminal records check as determined by the board's executive director or director's designee.

(ii) The name or names of the corporation.

(iii) The state of incorporation.

(iv) The corporation's federal employer identification number.

(v) The name of the parent company, if applicable.

(vi) If the corporation is not publicly traded on a major stock exchange, the full name, business address, and social security number of each shareholder owning ten percent or more of the voting stock of the corporation.

(e) For a government agency: the full name, business address, social security number, and date of birth of the agency director.

(f) For a nonprofit organization: the full name, business address, social security number, and date of birth of the executive director or any equivalent position.

(6) If the entity submitting an application for a distributor of dangerous drugs license is located outside the boundaries of the state of Ohio, the licensing process shall include an inquiry to the licensing authority of the state where located to determine if the entity possesses a current and valid license or registration to distribute dangerous drugs in that state and any disciplinary action, including actions pending, the licensing authority is taking or may have taken against the entity. This information may be used to determine if the business entity should be granted a license by the state board of pharmacy. An entity located outside the boundaries of the state of Ohio that is making application for licensure as a third-party logistics provider or virtual wholesaler shall maintain an applicable accreditation from the national association of boards of pharmacy if the state where the entity resides does not license such entities.

(7) If applicable, proof of the entity's valid registration with the United States food and drug administration and/or the United States drug enforcement administration.

(8) Any information required on the application as determined by the board.

(9) Any follow-up information as deemed necessary by the board's executive director or the director's designee upon receipt of the application materials.

(B) Prior to the end of the licensing period established in rule 4729:6-2-02 of the Administrative Code, a renewal application requesting such information as the state board of pharmacy may require will be sent to the email or physical address of record to the attention of the responsible person. Such renewal application form shall be completed and returned with the applicable fee on or before the date established in rule 4729:6-2-02 of the Administrative Code.

(D) Except as provided in paragraph (D)(1) of this rule, an applicant or licensee engaged in the distribution of dangerous drugs shall obtain all applicable licenses issued in accordance with this division of the Administrative Code.

(1) This provision does not apply to a manufacturer who is also engaged in the wholesale distribution of dangerous drugs.

(2) An applicant or licensee engaged in activities requiring multiple licenses shall ensure that all requirements for each license can be maintained and all applicable drug records are segregated by license type.

Last updated September 3, 2024 at 8:37 AM

History

Effective: August 31, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-2-06 Procedure for discontinuing business as a distributor of dangerous drugs.

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

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

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

(3) The name and address of the secured location where the records required to be maintained in accordance with this division will be stored.

(4) The proposed date of discontinuing business.

(B) Unless the licensee is informed by the executive director before the proposed date of discontinuing business that the transfer of dangerous drugs and records may not occur, the licensee discontinuing business may transfer the dangerous drugs and drug records.

(C) On the date of discontinuing business, a complete inventory of all controlled substances being transferred, or disposed pursuant to rule 4729:6-3-01 of the Administrative Code, shall be made. The inventory shall list the name, strength, dosage form, and quantity of all controlled substances transferred 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.

Last updated May 19, 2025 at 8:03 AM

History

Effective: May 19, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-01

(A) As used in this rule:

"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.

(B) A person licensed in accordance with section 4729.52 of the Revised Code or this division of the Administrative Code 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 five years and made readily retrievable to the board of pharmacy upon request.

Last updated September 3, 2024 at 8:37 AM

History

Effective: August 31, 2024
Promulgated Under: 119.03

Chapter 4729:6-3 General Provisions

Ohio Adm.Code 4729:6-3-01 Disposal of controlled substances.

(A) As used in this rule:

Last updated September 3, 2024 at 8:37 AM

History

Effective: August 31, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-02 Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents.

(A) A person licensed in accordance with section 4729.52 of the Revised Code or this division of the administrative code 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 by a licensee shall be reported by 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-fivedays.

(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 by a licensee to the state board of pharmacy, in a manner determined by the board, 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 person licensed in accordance with section 4729.52 of the Revised Code or this division of the Administrative Code 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 person licensed in accordance with section 4729.52 of the Revised Code or this division of the Administrative Code 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 DEA form 222.

Last updated August 10, 2026 at 7:51 AM

History

Effective: August 8, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-03 Inspections and corrective actions.

(A) Pursuant to section 3719.13 of the Revised Code, an entity licensed by state board of pharmacy in accordance with section 4729.52 of the Revised Code or this division of the Administrative Code 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, in accordance with section 4729.52 of the Revised Code or this division of the Administrative Code, 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 December 30, 2024 at 8:13 AM

History

Effective: December 30, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-04 Verification of licensure prior to sale or purchase.

(A) As used in section 4729.60 of the Revised Code and in this rule, "roster" means any of the following:

(1) The online roster maintained as part of the board's electronic licensing system (available on the board's website: www.pharmacy.ohio.gov);

(2) An electronic list of licensees and registrants if maintained by the board; and

(3) Any other format capable of meeting the requirements of section 4729.60 of the Revised Code and this rule that has been approved by the board.

(B) Before a drug distributor may sell or distribute dangerous drugs to any person in this state, except as provided in paragraph (C) of this rule, the distributor shall conduct a documented query of a roster maintained by the board 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 drug 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.

(C) Paragraph (B) of this rule does not apply when a drug distributor sells or distributes dangerous drugs to any of the following:

(1) A person specified in division (B)(4) of section 4729.51 of the Revised Code; or

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

(D) A distributor of dangerous drugs may make a sale of a dangerous drug to any of the exempted persons listed in section 4729.541 of the Revised Code and shall ensure the purchaser meets the exemption criteria.

(1) To confirm a purchasing prescriber meets the exemption criteria pursuant to section 4729.541 of the Revised Code, the drug distributor shall comply with all the following:

(a) Provide the prescriber the requirements in Ohio law of when a prescriber is required to hold a license as a terminal distributor of dangerous drugs;

(b) Verify the prescriber is appropriately licensed in this state to prescribe dangerous drugs or drug therapy related devices in the course of the individual's professional practice;

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

(d) Ensure that all attestations are maintained by the drug distributor for a period of five years after the sale or distribution of the dangerous drug.

(2) To confirm any other person purchasing dangerous drugs meets the exemption criteria pursuant to section 4729.541 of the Revised Code, the drug distributor shall comply with all the following:

(a) Provide the person the requirements in Ohio law of when a person is required to hold a license as a terminal distributor of dangerous drugs;

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

(c) Ensure that all attestations are maintained by the drug distributor for a period of five years after the sale or distribution of the dangerous drug.

(E) Except as provided in paragraph (F) of this rule, before a drug distributor located in this state may purchase or receive dangerous drugs, the distributor shall conduct a documented query of a roster maintained by the board to determine if the seller is licensed as a distributor of dangerous drugs. If a licensed drug distributor conducts a documented query at least annually and relies on the results of the query in purchasing dangerous drugs, the distributor shall be deemed not to have violated this rule.

(F) A third-party logistics provider is exempt from the requirements of paragraph (B) of this rule if the licensee has access to documentation indicating the entity responsible for directing the sale or disposition of the drugs has complied with the requirements of this rule.

Last updated September 3, 2024 at 8:38 AM

History

Effective: August 31, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-05 Suspicious order monitoring and due diligence.

(A) As used in this rule:

(1) "Customer" means a person located in this state that orders or seeks to order a reported drug from an Ohio licensed drug distributor and includes the following:

(a) A licensed terminal distributor of dangerous drugs; or

(b) A prescriber who possesses, or possesses for sale or sells, at retail, a dangerous drug.

(2) "Prescriber" has the same meaning as in section 4729.01 of the Revised Code.

(3) "Reported drug" means any dangerous drug whose sale is required to be reported to the drug database pursuant to division 4729:8 of the Administrative Code. A reported drug shall not include any list I or list II chemicals listed in 21 CFR Section 1310.02 (10/31/2023).

(B) This rule only applies to the following drug distributors licensed in accordance with section 4729.52 of the Revised Code:

(1) Wholesale distributors of dangerous drugs;

(2) Virtual wholesalers;

(3) Manufacturers of dangerous drugs; and

(4) Outsourcing facilities.

(C) Drug distributors listed in paragraph (B) of this rule shall design and operate a system to identify and report suspicious orders by customers for reported drugs. Suspicious orders shall include, but are not limited to, the following:

(1) Orders of unusual size;

(2) Orders deviating substantially from a normal pattern; and

(3) Orders of unusual frequency.

(D) Prior to any shipment of an order that a distributor has identified as suspicious, two persons designated by the distributor's responsible person must independently analyze the order. In order to proceed with the shipment and complete the sale, each of the two people designated must determine that the order is not likely to be diverted from legitimate channels.

(E) All suspicious orders, regardless of actual sale, shall be submitted electronically in a manner and format determined by the board. The electronic submission of suspicious orders shall include all information as required by the board and shall be submitted within five days of the order being identified as suspicious by the drug distributor.

(F) All drug distributors listed in paragraph (B) of this rule shall submit a zero report, in a manner determined by the board, if no suspicious orders have been identified by the distributor in a calendar month. The zero report shall be submitted within fifteen days of the end of the calendar month.

(G)

(1) Except as provided in paragraph (G)(2) of this rule, a drug distributor listed in paragraph (B) of this rule shall exercise due diligence to identify customers ordering or seeking to order reported drugs to establish the normal and expected transactions conducted by those persons and to identify and prevent the sale of reported drugs that are likely to be diverted from legitimate channels. Such measures shall include, but are not limited to, the following which shall be conducted prior to an initial sale and on an annual basis:

(a) Questionnaires and affirmative steps by the drug distributor to confirm the accuracy and validity of the information provided.

(b) For a customer who is a prescriber, confirmation of prescriber type (physician, dentist, veterinarian, etc.), specialty practice area (oncology, geriatrics, pain management, etc.) and if the prescriber personally furnishes reported drugs and the quantity personally furnished.

(d) Obtaining and conducting a review of the following information:

(i) The methods of payment accepted (cash, insurance, medicaid, medicare) and in what ratios;

(ii) The ratio of controlled vs. non-controlled drug orders and overall sales;

(iii) Orders for reported drugs from other drug distributors made available by the United States drug enforcement administration's automation of reports and consolidated orders system; and

(iv) The proportion of out-of-state patients served compared to in-state patients.

(2) A drug distributor receiving a request for an initial sale for a reported drug may conduct the sale without complying with paragraph (G)(1) of this rule if all the following applies:

(a) The sale is to an institutional facility as defined in Chapter 4729:5-9 of the Revised Code that is a new customer of the distributor;

(b) The drug distributor documents that the order is to meet an emergent need; and

(c) The drug distributor completes the requirements set forth in paragraph (G)(1) of the rule no later than sixty days from the date of sale.

(H) Any customer that may be engaging in possible activities that may cause reported drugs to be diverted from legitimate channels, including those to whom a drug distributor refuses to sell, shall be electronically reported by the drug distributor in a manner and format determined by the board. The electronic submission of such customers shall include all information as required by the board and shall be submitted within five days of refusal, cessation or identification by the drug distributor.

(I) All drug distributors described in paragraph (B) of this rule shall maintain and implement policies and procedures that include all the following:

(1) The design and operation of a suspicious order monitoring and reporting system.

(2) A system to collect the necessary information on customers in accordance with paragraph (G) of this rule.

(3) Mandatory training, to be conducted annually, for staff responsible for the processing of all orders for reported drugs that includes all the following:

(a) The drug distributor's suspicious order monitoring system;

(b) The process to collect all relevant information on customers in accordance with paragraph (G) of this rule;

(c) The process for submission of suspicious orders and customers who may be engaging in possible activities that may cause reported drugs to be diverted from legitimate channels to the board; and

(d) Information on submitting a confidential report of a suspicious order or customer engaging in possible activities that may cause reported drugs to be diverted from legitimate channels by using the board's online electronic complaint form that can accessed by visiting: www.pharmacy.ohio.gov. The training shall remind all employees that complaints and all information submitted that identifies a complainant shall remain confidential pursuant to section 4729.23 of the Revised Code.

(J) All policies and procedures maintained in accordance with paragraph (I) of this rule shall be reviewed and updated on an annual basis.

Last updated December 30, 2024 at 8:13 AM

History

Effective: December 30, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-06 Controlled substances inventory requirements.

(A) All category III drug distributor licenses shall complete a controlled substances inventory in accordance with 21 CFR 1304.11 (9/9/2014).

(B) The drug distributor's responsible person shall be responsible for completing and maintaining this inventory record.

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

Last updated September 3, 2024 at 8:38 AM

History

Effective: August 31, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-07 Sales of dangerous drugs on-line.

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

(B) All drug distributors licensed with the state board of pharmacy and who sell or offer to sell dangerous drugs 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) Websites owned and/or maintained by Ohio licensed dangerous drug distributors who sell or offer to sell dangerous drugs on the internet must provide the following information to the public:

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

(2) Full address of licensed location.

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

(4) A list of the states in which the dangerous drug 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.

(D) Any Ohio licensed drug distributor requesting personal information from the public by way of the internet (e.g., questionnaire forms or e-mail) 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.

Last updated September 3, 2024 at 8:38 AM

History

Effective: August 31, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-08 Distributor of dangerous drugs samples and complimentary supplies.

(A) As used in this rule:

(1) "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. Except as provided in paragraph (E) of this rule, samples may only be provided to and furnished by a licensed prescriber as defined in rule 4729:5-1-02 of the Administrative Code in accordance with paragraph (B) of this rule.

(2) "Complimentary supply" also known as "starter packs," "initial dose packs," "starter stocks," "replacement programs," or any other similar supply means a drug or pharmaceutical preparation that is distributed without charge by licensed drug distributors to pharmacies licensed as terminal distributors of dangerous drugs or prescribers to assist patients in the initiation of drug therapy. A complimentary supply shall not contain the markings or labeling of a sample drug.

(B) No drug distributor or distributor's representative, including sales representatives, may sell or distribute a sample of a drug to a licensed prescriber unless requested by the prescriber and the entity:

(1) Is licensed as a distributor of dangerous drugs or is exempted from licensure in accordance with section 4729.541 of the Revised Code; and

(2) Maintains a record of such distribution for five years from the date of sale or distribution. Such records shall be made readily retrievable.

(C) Complimentary supplies are subject to the same requirements as stock shipments of dangerous drugs pursuant to agency 4729 of the Administrative Code and Chapters 4729., 3719., and 3715. of the Revised Code.

(D) A drug distributor shall comply with rule 4729:6-3-04 of the Administrative Code prior to the sale or distribution of complimentary supplies and samples.

(E) Nothing in this rule prohibits a pharmacist working, regardless of compensation, in a charitable pharmacy from dispensing a sample drug to a person in accordance with section 3719.811 of the Revised Code and agency 4729 of the Administrative Code.

(F) Paragraph (A)(1) of this rule does not permit a pharmacist who is authorized to manage drug therapy pursuant section 4729.39 of the Revised Code from ordering, dispensing, or personally furnishing a sample within a pharmacy licensed as a terminal distributor of dangerous drugs.

Last updated September 3, 2024 at 8:38 AM

History

Effective: August 31, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:6-3-09 Satellite distribution sites during a public health emergency.

(A) Upon the governor's declaration of an emergency that affects the public health, the director of health may establish satellite distribution sites under an existing wholesale distributor of dangerous drugs license held by the department. The satellite distribution sites entitle each location to distribute dangerous drugs in accordance with section 4729.52 of the Revised Code.

(B) The director of health shall notify the board in writing prior to establishing a satellite distribution site in accordance with paragraph (A) of this rule.

(C) A satellite distribution site established by the director of health shall comply with all security and recordkeeping requirements for the distribution of dangerous drugs in accordance with this division of the Administrative Code.

(D) All satellite distribution 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.

(E) 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

Chapter 4729:6-4 Discipline

Ohio Adm.Code 4729:6-4-01 Disciplinary actions.