Ohio Adm.Code 4729:7 | Ohio Administrative Code 4729:7 — State Board of Pharmacy | Drug Compounding

Chapter 4729:7-1 Compounding References

Ohio Adm.Code 4729:7-1-01 Compounding references.

As used in this division and in agency 4729 of the Administrative Code:

(A) "The national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings" means publication number 2025-103 (December 2024).

(B) "United States Pharmacopeia Chapter <795>" or "USP <795>" means United States Pharmacopeia Chapter <795> (November 1, 2023).

(C) "United States Pharmacopeia Chapter <797>" or "USP <797>" means United States Pharmacopeia Chapter <797> (February 1, 2026).

(D) "United States Pharmacopeia Chapter <800>" or "USP <800>" means United States Pharmacopeia Chapter <800> (December 1, 2022).

(E) The board may grant an existing licensee a temporary extension to the requirements to comply with the standards listed in paragraphs (B) and (C) of this rule if the licensee can demonstrate all of the following:

(1) The licensee was compliant with the standards in effect immediately prior to the effective date of this rule;

(2) Significant hardship in meeting the standards; and

(3) Sufficient progress towards compliance with the standards.

Last updated June 1, 2026 at 8:09 AM

History

Effective: June 1, 2026
Promulgated Under: 119.03

Chapter 4729:7-2 Pharmacy Compounding

Ohio Adm.Code 4729:7-2-01 Definitions - pharmacy compounding.

As used in this chapter of the Administrative Code:

(A) "Antineoplastic" means a dangerous drug that blocks the formation of neoplasms.

(B) "Beyond-use date" means either the date or time and date after which a compounded drug preparation must not be used or administration must not begin. The beyond-use date is determined from the date/time that preparation of the compounded drug is initiated.

(C) "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.

(D) "Compounding" means the preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding includes the combining, admixing, mixing, diluting, pooling, reconstituting, repackaging, or otherwise altering of a drug or bulk drug substance. A pharmacy engaged in the following shall not be required to comply with the provisions of this chapter:

(1) 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. A pharmacist shall perform the final check of the product.

(2) The preparation of radiopharmaceuticals as defined in agency 4729 of the Administrative Code.

(3) Sterile compounded drug preparations in accordance with rule 4729:7-2-02 of the Administrative Code.

(4) The addition of a flavoring agent to a conventionally manufactured drug product.

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

(F) "Dilution" means a process of reducing the concentration of a solute in solution, usually by mixing with a solvent.

(G) "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.

(H) "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.

(I) "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.

(J) "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.

(K) "Non-resident pharmacy" means any pharmacy, licensed as a terminal distributor of dangerous drugs in accordance with Chapter 4729:5-8-01 of the Administrative Code, located outside of Ohio that ships, mails, or delivers, in any manner, drugs at retail into Ohio.

(L) "Non-sterile compounded drug" means a dangerous drug preparation intended to be non-sterile. Non-sterile compounded drugs include, but are not limited to, the preparation of solutions, suspensions, ointments, creams, powders, suppositories, capsules, and tablets.

(M)

(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 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;

(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) "Preparation" means a drug compounded in a licensed pharmacy or other healthcare-related facility. Preparations may include the compounding of one or more drug products.

(O) "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.

(P) "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.

(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) "Reconstitution" means the process of adding a diluent to a powdered drug to prepare a solution or suspension.

(S) "Responsible person" has the same meaning as in rule 4729:5-2-01 of the Administrative Code who is responsible for 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.

(T) "Sterile" means a dosage form free of living microorganisms (aseptic).

(U) "Sterile compounded drug" means a dangerous drug preparation intended to be sterile.

(V) "United States Pharmacopeia Chapter <795>" or "USP <795>" has the same meaning as in rule 4729:7-1-01 of the Administrative Code.

(W) "United States Pharmacopeia Chapter <797>" or "USP <797>" has the same meaning as in rule 4729:7-1-01 of the Administrative Code.

(X) "United States Pharmacopeia Chapter <800>" or "USP <800>" has the same meaning as in rule 4729:7-1-01 of the Administrative Code.

Last updated July 1, 2021 at 11:13 AM

History

Effective: July 1, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-2-02

The following sterile drug compounding is exempted from the requirements of this chapter:

Preparation of a non-hazardous, conventionally manufactured sterile products in accordance with the directions contained in approved labeling provided by the product's manufacturer if preparation complies with all the following:

(A) Administration of the drug product must begin within one hour of beginning the preparation (e.g., within one hour of initial entry into or puncture of a single-dose container).

(B) Aseptic technique must be followed. Procedures must be in place to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, and mix-ups with other products or compounded sterile preparations.

(C) A pharmacist or prescriber performs the final check of the product and documents that it was conducted using positive identification.

(D) Any unused starting ingredient that is not labeled as a multiple dose container must be discarded after preparation is complete.

(E) Unless administered immediately, the drug product described in this paragraph shall bear a label listing the name of the drug (if not legible) and date and time prepared or beyond-use date.

Last updated September 11, 2023 at 11:40 AM

History

Effective: July 1, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-1-01

As used in this division and in agency 4729 of the Administrative Code:

(A) "The national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings" means publication number 2025-103 (December 2024).

(B) "United States Pharmacopeia Chapter <795>" or "USP <795>" means United States Pharmacopeia Chapter <795> (November 1, 2023).

(C) "United States Pharmacopeia Chapter <797>" or "USP <797>" means United States Pharmacopeia Chapter <797> (February 1, 2026).

(D) "United States Pharmacopeia Chapter <800>" or "USP <800>" means United States Pharmacopeia Chapter <800> (December 1, 2022).

(1) The licensee was compliant with the standards in effect immediately prior to the effective date of this rule;

(2) Significant hardship in meeting the standards; and

(3) Sufficient progress towards compliance with the standards.

Last updated June 1, 2026 at 8:09 AM

History

Effective: June 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-2-03 Drugs compounded in a pharmacy.

(A) For all non-sterile compounded drug preparations, the pharmacy shall comply with United States pharmacopeia chapter <795>. This paragraph does not apply to non-sterile compounded preparations exempted from the requirements of this chapter in accordance with paragraph (C) of rule 4729:7-2-01 of the Administrative Code.

(B) For all sterile compounded drug preparations, the pharmacy shall comply with United States pharmacopeia chapter <797>. This paragraph does not apply to sterile compounded drugs exempted from the requirements of this chapter in accordance with rule 4729:7-2-02 of the Administrative Code.

(C) 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, the pharmacy shall comply with United States pharmacopeia chapter <800>.

(D) 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, the pharmacy 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 (D) 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 (D)(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 (D) of this rule.

(E) Comply with Title 21 U.S. Code section 353a (11/27/2013).

(F) Only the following may engage in compounding at a pharmacy:

(1) A pharmacist;

(2) A pharmacy intern under the personal supervision of a pharmacist;

(3) A certified pharmacy technician, registered pharmacy technician, or pharmacy technician trainee under the personal supervision of a pharmacist.

(G) For all compounded drug preparations, a pharmacist shall:

(1) Conduct the final check of the compounded drug preparation; and

(2) Be responsible for the dispensing of a compounded drug preparation.

(H) For all compounded drug preparations, a pharmacist shall be responsible for the following:

(1) All compounding records pursuant to rule 4729:7-2-04 of the Administrative Code;

(2) The proper maintenance, cleanliness, and use of all equipment used in compounding.

(I) A drug shall be compounded and dispensed pursuant to a patient-specific prescription issued by a licensed health professional authorized to prescribe drugs. A limited quantity may be compounded in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

(J) In addition to the requirements of this rule, compounded drug preparations dispensed to an outpatient shall comply with the following requirements:

(1) Be labeled according to rule 4729:5-5-06 of the Administrative Code; and

(2) The statement "Compounded Drug" or other similar statement shall also be displayed prominently on the label.

(K) In addition to the requirements of this rule, compounded drug preparations dispensed to an inpatient shall be labeled according to the inpatient labeling requirements in agency 4729 of the Administrative Code; and

(L) Labels for a compounded drug that is prepared in anticipation of a patient-specific prescription shall also contain the following:

(1) The name, strength, and quantity of each active ingredient used in the compounded drug preparation;

(2) Pharmacy control number;

(3) The assigned beyond-use date;

(4) The identification of the repackager or outsourcing facility by name, by the final seven digits of its terminal distributor of dangerous drugs license number, or any other board approved identifier;

(5) The statement "Compounded Drug" or other similar statement shall also be displayed prominently on the label.

(M) A prescription for a schedule II controlled substance narcotic to be compounded for the direct administration to a patient may be transmitted to a pharmacy by facsimile. The prescription shall comply with the requirements of 21 CFR 1306.11 (3/31/2010).

(N) The pharmacy shall maintain a system for the safe disposal of drug waste in accordance with all state and federal laws, rules and regulations.

(O) The pharmacy shall comply with the drug database reporting requirements pursuant to division 4729:8 of the Administrative Code.

(P) A pharmacy 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.

(Q) A pharmacy 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.

Last updated October 22, 2025 at 11:14 AM

History

Effective: March 7, 2024
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-2-04

(A) In addition to the pharmacy record keeping requirements of agency 4729 of the Administrative Code, a pharmacy shall maintain records of all drugs compounded that include, at a minimum, all the following:

(1) The name of the patient;

(2) Name of drug, strength or activity, and dosage form;

(3) Assigned internal identification number (e.g., prescription, order, lot number);

(4) Date and time of preparation;

(5) Name of each ingredient;

(6) Vendor, lot number, and expiration date for each ingredient for compounded drug preparations prepared for more than one patient and for any sterile compounded product prepared from nonsterile ingredient(s);

(7) Weight or volume of each ingredient;

(8) Total quantity compounded;

(9) The disposition of unused controlled substances drug(s) and amount;

(10) Assigned beyond-use date;

(11) The positive identification of the following:

(a) The pharmacy personnel responsible for preparing the compounded drug preparation;

(b) The pharmacist conducting the final check of the compounded drug preparation; and

(12) All other drug compounding records as required by USP 795, USP 797, and USP 800.

(B) 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 (B)(2) of this rule, all records maintained in accordance with this rule shall be kept on-site.

(2) A pharmacy located in this state intending to maintain records pursuant to this rule at an alternate location must first send a written request to the state board of pharmacy. The request shall contain the pharmacy's name and license number and the name and address of the alternate location. The state board of pharmacy will send written notification to the pharmacy documenting the approval or denial of the request. A copy of the board's approval shall be maintained with the other records of dangerous drugs. Any such alternate location shall be secured and accessible only to authorized personnel or contractors of the pharmacy.

Last updated July 1, 2021 at 11:14 AM

History

Effective: July 1, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-06

(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 4729:7-2-05 Drugs compounded for veterinarian office use.

(A) This rule only applies to compounded drugs intended for animal use by licensed veterinarians.

(B) Pharmacies located in Ohio shall comply with the applicable compounding requirements of this chapter.

(C) Pharmacies licensed as nonresident terminal distributors shall comply with the applicable requirements of rule 4729:5-8-04 of the Administrative Code.

(D) In accordance with applicable federal laws and regulations, a pharmacy licensed as a terminal distributor of dangerous drugs may sell, without a prescription, a non-patient specific compounded drug pursuant to a request made by a veterinarian, or by an agent of the veterinarian, for a drug to be used by the veterinarian for the purpose of the direct administration to patients in the course of the veterinarian's practice pursuant to division (C)(5) of section 4729.01 of the Revised Code and all the following:

(1) The pharmacy shall only provide compounded drug preparations that are not commercially available, as defined in division (C)(5) of section 4729.01 of the Revised Code, to a veterinarian for any of the following reasons:

(a) To treat an emergency situation;

(b) For an unanticipated procedure or treatment for which a time delay would negatively affect a patient outcome; or

(2) A limited quantity of the drug is compounded and provided to the veterinarian. "Limited quantity" means a quantity of a compounded drug preparation that meets all the following criteria:

(a) Is sufficient for that veterinarian's office use consistent with the beyond-use date of the preparation;

(b) Is reasonable considering the intended use of the compounded preparation and nature of the veterinarian's practice; and

(c) The pharmacist who provides the veterinarian with a compounded drug preparation exercises their professional judgment as to whether the quantity of the drug is appropriate.

(E) A veterinarian may personally furnish up to a seven-day supply of a compounded drug provided in accordance with this rule to a patient when, in their professional judgment, failure to provide the drug would result in potential harm to the patient.

(F) A pharmacy shall not sell a compounded drug to another pharmacy or facility licensed in accordance with division 4729:6 of the Administrative Code.

(G) Veterinarians shall not:

(1) Sell a compounded drug to another prescriber;

(2) Sell a compounded drug to a pharmacy;

(3) Sell a compounded drug to an entity licensed in accordance with division 4729:6 of the Administrative Code; or

(4) Return a compounded drug to the supplying pharmacy, unless there is a documented error or recall.

(H) The sale of a compounded drug preparation to a veterinarian or a veterinary clinic or animal shelter licensed as a terminal distributor of dangerous drugs is considered an occasional sale pursuant to rule 4729:5-3-09 of the Administrative Code. For the purposes of enforcing paragraph (B) of rule 4729:5-3-09 of the Administrative Code, the limit for nonresident terminal distributors shall be based on the pharmacy's total sales to persons residing in this state.

Last updated July 1, 2021 at 11:14 AM

History

Effective: July 1, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-8-04

(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 4729:5-3-09

(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

Chapter 4729:7-3 Prescriber Compounding

Ohio Adm.Code 4729:7-3-01 Definitions - prescriber compounding.

As used in Chapter 4729:7-3 of the Administrative Code:

(A) "Antineoplastic" means a dangerous drug that blocks the formation of neoplasms.

(B) "Beyond-use date" or "beyond-use dating" means either the date or time after which a compounded drug preparation must not be used, or administration must not begin, and must be discarded. The beyond-use date is determined from the date/time that preparation of the compounded drug is initiated.

(C) "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.

(D) "Compounding" means the preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding includes the combining, admixing, mixing, diluting, reconstituting, or otherwise altering of a drug or bulk drug substance.

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

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

(G) "Dilution" means a process of reducing the concentration of a solute in solution, usually by mixing with a solvent.

(H) "Hazardous drug" means any antineoplastic 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.

(I) "Immediate use" or "immediate use drug" means the immediate preparation of a sterile non-hazardous compounded drug preparation in accordance with rule 4729:7-3-04 of the Administrative Code.

(K) "Non-sterile compounded drug" means a dangerous drug preparation intended to be non-sterile. Non-sterile compounded drugs include, but are not limited to, the preparation of solutions, suspensions, ointments, creams, powders, suppositories, capsules, and tablets.

(L) "Outsourcing facility" means a facility that is engaged in the compounding and sale of sterile drugs, is registered as an outsourcing facility with the United States food and drug administration, and is licensed in accordance with section 4729.52 of the Revised Code.

(M) "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.

(N)

(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.

(O) "Preparation" means a drug compounded in a licensed pharmacy or other healthcare-related facility. Preparations may include the compounding of one or more drug products.

(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 FDA-approved manufacturer's labeling or product package insert.

(R) "Reconstitution" means the process of adding a diluent to a powdered drug to prepare a solution or suspension.

(S) "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.

(T) "Sterile" means a dosage form free of living microorganisms (aseptic).

(U) "Sterile compounded drug" means a dangerous drug preparation intended to be sterile.

(V) "United States Pharmacopeia Chapter <795>" or "USP <795>" has the same meaning as in rule 4729:7-1-01 of the Administrative Code.

(W) "United States Pharmacopeia Chapter <797>" or "USP <797>" has the same meaning as in rule 4729:7-1-01 of the Administrative Code.

(X) "United States Pharmacopeia Chapter <800>" or "USP <800>" has the same meaning as in rule 4729:7-1-01 of the Administrative Code.

Last updated July 10, 2025 at 12:15 PM

History

Effective: March 31, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-1-01

As used in this division and in agency 4729 of the Administrative Code:

(A) "The national institute for occupational safety and health's list of antineoplastic and other hazardous drugs in healthcare settings" means publication number 2025-103 (December 2024).

(B) "United States Pharmacopeia Chapter <795>" or "USP <795>" means United States Pharmacopeia Chapter <795> (November 1, 2023).

(C) "United States Pharmacopeia Chapter <797>" or "USP <797>" means United States Pharmacopeia Chapter <797> (February 1, 2026).

(D) "United States Pharmacopeia Chapter <800>" or "USP <800>" means United States Pharmacopeia Chapter <800> (December 1, 2022).

(1) The licensee was compliant with the standards in effect immediately prior to the effective date of this rule;

(2) Significant hardship in meeting the standards; and

(3) Sufficient progress towards compliance with the standards.

Last updated June 1, 2026 at 8:09 AM

History

Effective: June 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-3-04

(A) The responsible person of a facility where a prescriber is engaged in the compounding of immediate-use, sterile non-hazardous dangerous drug preparations in accordance with paragraph (B) of this rule shall be responsible for all the following:

(1) Developing and implementing appropriate compounding procedures;

(2) Overseeing facility compliance with this rule;

(3) Compliance with Title 21 U.S.C. section 353a (11/27/2013) and all other applicable federal and state laws, regulations and rules;

(4) Ensuring training and competency of compounding personnel;

(5) Ensuring that compounded drug preparations maintain quality and sterility until administered;

(6) Maintaining drug compounding records pursuant to rule 4729:7-3-06 of the Administrative Code;

(7) The proper maintenance, cleanliness, and use of all equipment used in compounding; and

(8) Ensuring aseptic technique for the preparation of all sterile compounded drugs.

(B) Immediate-use, sterile compounded drug preparations are exempt from the requirements in rule 4729:7-3-03 of the Administrative Code if all the following criteria are met:

(1) The compounding process involves the simple transfer of not more than three commercially manufactured products of sterile, non-hazardous drugs from the manufacturers' original containers and not more than two entries into any one container or package (e.g., bag, vial) of sterile infusion solution or administration container/device.

(2) Personnel shall adhere to appropriate aseptic technique, including all the following:

(a) Before beginning compounding activities, personnel shall perform a thorough hand-hygiene procedure; and

(b) Compounding personnel shall don gloves prior to engaging in compounding activities.

(3) If not immediately administered, the finished compounded drug preparation shall be regularly monitored by compounding personnel to minimize the potential for contact with non-sterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other compounded drug preparations, and direct contact of outside surfaces.

(4) The beyond-use date for an immediate-use compounded drug preparation is as follows:

(a) Except as provided in paragraph (B)(4)(b) of this rule, no later than six-hours following preparation of the drug.

(b) For preparations of buffered lidocaine containing antimicrobial preservatives, no later than twelve-hours following preparation of the drug.

(5) If administration has not begun within the beyond-use dating described in paragraph (B)(4) of this rule, the drug shall be promptly, properly, and safely disposed. Records of disposal shall be maintained in accordance with rule 4729:7-3-06 of the Administrative Code.

(6) Unless administered immediately, the compounded drug preparation shall bear a label listing all the following:

(a) Except for preparations compounded in accordance with paragraph (G)(2) of this rule, patient identification information, including the patient's first and last name;

(b) The name and quantity of each ingredient;

(d) The name or initials of the person who prepared the compounded drug preparation.

(7) Immediate-use compounded drug preparations are for administration only and shall not be personally furnished by a prescriber.

(8) For an immediate-use compounded drug preparation administered via injection, a new sterile needle shall be used to administer the compounded drug preparations to the patient.

(C) Unless administered within one-hour of preparation, sterile compounded drug preparations for immediate-use shall be prepared in a designated clean medication area that is not adjacent to areas where potentially contaminated or hazardous items are placed. Such an area shall be limited to compounding personnel and shall not be in a location that has unsealed windows or doors that connect to the outdoors or high traffic flow, or that is adjacent to construction sites, warehouses, or food preparation. Cleaning and disinfection agents must be selected and used with careful consideration of compatibility, effectiveness, and inappropriate or toxic residues. Cleaning and disinfecting shall occur before compounding is performed. This shall be followed by wiping with a residue-free disinfecting agent, such as sterile seventy per cent isopropyl alcohol, which is allowed to dry before compounding begins.

(D) Preparations that do not meet the criteria listed in paragraph (B) of this rule shall not be prepared as immediate-use.

(E) Preparations that do not meet all the requirements listed in paragraph (B) of this rule shall comply with the requirements in rule 4729:7-3-03 of the Administrative Code.

(F) Immediate-use compounded drug preparations shall be prepared in accordance with this rule except in an emergency, as documented in the medical record, when the product is required to treat the immediate needs of a patient whose health would otherwise be jeopardized.

(G)

(1) Except as provided in paragraph (G)(2) of this rule, compounding for anticipated needs or engaging in compounding practices where multiple non-patient specific doses are produced in a single activity is prohibited.

(2) A prescriber may compound preparations of buffered lidocaine containing antimicrobial preservatives for anticipated needs where multiple non-patient specific doses are produced in a single activity.

(H) Records of drug compounding shall be maintained pursuant to rule 4729:7-3-06 of the Administrative Code.

(I)

(1) Except as provided for in paragraph (I)(2) of this rule, this rule does not apply to a prescriber who is a veterinarian licensed under Chapter 4741. of the Revised Code. If preparing or handling hazardous drug preparations, a prescriber who is a veterinarian shall comply with rule 4729:7-3-05 of the Administrative Code.

(2) A veterinarian engaged in the compounding of immediate-use sterile drug preparations shall comply with the following:

(a) Unless administered immediately, the compounded drug preparation shall bear a label listing all of the following:

(i) Patient identification information, including the full name of the owner, if applicable, and the name or identification of the animal;

(ii) The name and quantity of each ingredient;

(iii) The date and time prepared; and

(iv) The name or initials of the person who prepared the compounded drug preparation.

(J) For hazardous compounded drugs, the prescriber shall comply with rule 4729:7-3-05 of the Administrative Code.

(K) A prescriber may designate an appropriately trained agent to prepare compounded drug preparations.

(L) For all compounded drugs prepared pursuant to this rule, a prescriber shall:

(1) Inspect and approve the compounding process; and

(2) Except as provided in paragraph (M) of this rule, perform medication validation ("final check") prior to the medication being administered.

(M) The requirements of paragraph (L)(2) of this rule do not apply to either of the following:

(1) A compounded drug preparation is being administered to a patient in the facility by a nurse licensed under Chapter 4723. of the Revised Code pursuant to a prescriber's order and, prior to administration, at least two nurses that are approved by the responsible person to prepare or administer compounded drugs comply with the requirements in paragraph (N) of this rule; or

(2) A compounded drug preparation is prepared and administered to a patient in the facility by a nurse licensed under Chapter 4723. of the Revised Code pursuant to a prescriber's order and, prior to administration, the same nurse complies with paragraph (N) of this rule.

(N) All the following are required to administer a compounded drug preparation in accordance with paragraphs (M)(1) and (M)(2) of this rule:

(1) Verify patient identification using at least two identifiers (e.g., last name, medical record number, DOB, etc.).

(2) Confirm with the patient the patient's planned treatment, drug route, and symptom management.

(3) Verify the accuracy of:

(a) Drug name;

(b) Drug strength and dosage form;

(d) Rate of administration;

(e) Route of administration;

(f) Expiration dates/times;

(g) Appearance and physical integrity of the drugs.

(4) Indicate in the compounding record verification was completed.

(5) A licensed prescriber is on-site and immediately available.

Last updated March 2, 2026 at 8:35 AM

History

Effective: February 28, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-3-02 Exemptions.

(A) Licensing exemptions.

Persons listed in divisions (A)(1) to (A)(3) of section 4729.541 of the Revised Code shall be exempted from licensure as a terminal distributor of dangerous drugs as required in division (D)(1) of section 4729.541 of the Revised Code for any of the following:

(2) The preparation or reconstitution of non-hazardous, conventionally manufactured sterile dangerous drug products for direct administration with no intervening steps in accordance with the manufacturer's labeling for preparation, administration and beyond-use dating.

(3) The compounding, preparation, dilution or reconstitution of non-hazardous, non-sterile dangerous drug preparations.

(4) The possession of compounded dangerous drug preparations provided by an outsourcing facility.

(5) The dilution of non-hazardous, conventionally manufactured sterile dangerous drug products (e.g., diluting or mixing into a syringe to administer directly to the patient).

(B) Exemptions from the requirements of this chapter.

The following non-hazardous devices and drugs prepared by a licensed terminal distributor of dangerous drugs are exempted from the requirements of this chapter:

(1) The preparation of a device, as defined in Title 21 U.S. Code section 321 (12/13/2016), containing dangerous drugs strictly in accordance with the manufacturer's labeling for administration and beyond-use dating. Manufacturer labeling that uses the phrase "should" when referring to a beyond-use date or timeframe for use shall be construed by the licensee as the required beyond-use date of the device. If no such beyond-use date exists, the dangerous drug product may only be used for up to six hours following preparation. These devices shall be prepared using aseptic technique and procedures shall be in place to minimize the potential for contact with nonsterile surfaces and introduction of particulate matter or biological fluids. Unless administered immediately, the drug device described in this paragraph shall bear a label listing the name of the device (if not legible), date, and time prepared.

(2) The reconstitution of a conventionally manufactured sterile dangerous drug product with no intervening steps in accordance with the manufacturer's labeling for administration, and the beyond-use dating indicated on the manufacturer's labeling. Manufacturer labeling that uses the phrase "should" when referring to a beyond-use date or timeframe for use shall be construed by the licensee as the required beyond-use date of the drug product. If no such beyond use date or timeframe exists, the dangerous drug product may only be used for up to six hours following preparation. These drug products shall be prepared using aseptic technique and procedures shall be in place to minimize the potential for contact with nonsterile surfaces and introduction of particulate matter or biological fluids. Unless administered immediately, the drug product described in this paragraph shall bear a label listing the name of the drug (if not legible), date, and time prepared.

(3) The preparation, reconstitution or dilution of a conventionally manufactured nonsterile dangerous drug product with no intervening steps in accordance with the manufacturer's labeling for administration and beyond-use dating. Manufacturer labeling that uses the phrase "should" when referring to a beyond-use date or timeframe for use shall be construed by the licensee as the required beyond-use date of the drug product. If no such beyond-use date exists, the dangerous drug product shall be assigned a beyond-use date in accordance with USP <795>. Unless administered immediately, the drug product described in this paragraph shall bear a label listing the name of the drug (if not legible), date, and time prepared.

(4) The dilution of a conventionally manufactured sterile dangerous drug product (e.g., diluting or mixing into a syringe to administer directly to the patient). The drug product shall be prepared using aseptic technique and procedures shall be in place to minimize the potential for contact with nonsterile surfaces and introduction of particulate matter or biological fluids. The dangerous drug product may only be used for up to six hours following preparation. Unless administered immediately, the drug product described in this paragraph shall bear a label listing the name of the drug, date, and time prepared.

Last updated April 16, 2021 at 8:24 AM

History

Effective: April 16, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-3-03 Non-Hazardous Drugs Compounded by a Prescriber.

(A) Except as provided in paragraph (L) of this rule, all non-hazardous, non-sterile compounded drug preparations shall be prepared in accordance with United States pharmacopeia chapter <795>.

(B) Except as provided in paragraph (C) of this rule, all non-hazardous, sterile compounded drug preparations, shall be prepared in accordance with United States pharmacopeia chapter <797>.

(1) Rule 4729:7-3-04 of the Administrative Code; or

(2) United States pharmacopeia chapter <797>.

(D) For all hazardous non-sterile and sterile compounded drug preparations, a prescriber shall comply with rule 4729:7-3-05 of the Administrative Code.

(E) The responsible person of a facility where a prescriber is engaged in the compounding of dangerous drugs shall be responsible for all of the following:

(1) Developing and implementing appropriate compounding procedures;

(2) Overseeing facility compliance with this rule;

(3) Compliance with Title 21 U.S. Code section 353a (November 27, 2013) and all other applicable federal and state laws, regulations and rules;

(4) Ensuring documented training and competency of compounding personnel;

(5) Ensuring environmental control of the compounding areas;

(6) Ensuring compounded drug preparations maintain quality and sterility until administered or personally furnished;

(7) Maintaining drug compounding records pursuant to rule 4729:7-3-06 of the Administrative Code.

(8) The proper maintenance, cleanliness, and use of all equipment used in compounding; and

(9) Ensuring aseptic technique for the preparation of all sterile compounded drugs.

(F) A prescriber may designate an appropriately trained agent to prepare compounded drug preparations.

(G) For all compounded drugs prepared pursuant to this rule, a prescriber shall:

(1) Inspect and approve the compounding process; and

(2) Except as provided in paragraph (H) of this rule, perform medication validation ("final check") prior to the medication being administered.

(H) The requirements of paragraph (G)(2) of this rule do not apply to either of the following:

(I) All the following are required to administer a compounded drug preparation in accordance with paragraphs (H)(1) and (H)(2) of this rule:

(1) Verify patient identification using at least two identifiers (e.g., last name, medical record number, DOB, etc.).

(2) Confirm with the patient the patient's planned treatment, drug route, and symptom management.

(3) Verify the accuracy of:

(a) Drug name;

(b) Drug strength and dosage form;

(d) Rate of administration;

(e) Route of administration;

(f) Expiration dates/times;

(g) Appearance and physical integrity of the drugs.

(4) Indicate in the compounding record verification was completed;

(5) A licensed prescriber is on-site and immediately available.

(J) A prescriber shall not compound drug preparations unless a specific patient need exists. Compounding for anticipated needs or engaging in compounding practices where multiple non-patient specific doses are produced in a single activity is prohibited.

(K) A prescriber shall comply with the drug database reporting requirements for personally furnishing drugs pursuant to section 4729.79 of the Revised Code.

(L)

(1) Except as provided for in paragraph (L)(2) of this rule, the requirements of this rule do not apply to a prescriber who is a veterinarian licensed under Chapter 4741. of the Revised Code.

If preparing or handling compounded hazardous drugs, a prescriber who is a veterinarian shall comply with rule 4729:7-3-05 of the Administrative Code.

(2) A veterinarian engaged in the compounding of sterile and non-sterile drug preparations shall comply with the following:

(a) Unless administered immediately, the compounded drug preparation shall bear a label listing all of the following:

(i) Patient identification information, including the full name of the owner, if applicable, and the name or identification of the animal;

(ii) The name and quantity of each ingredient;

(iii) The date and time prepared;

(iv) The name or initials of the person who prepared the compounded drug preparation.

Last updated July 10, 2025 at 12:15 PM

History

Effective: March 31, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-3-05

(A) The responsible person of a facility where a prescriber is engaged in the compounding or handling of hazardous dangerous drugs shall be responsible for all of the following:

(1) Developing and implementing appropriate compounding policies and procedures;

(2) Overseeing facility compliance with this rule;

(3) Compliance with Title 21 U.S. Code section 353a (November 27, 2013) and all other applicable federal and state laws, regulations and rules;

(4) Ensuring training and competency of compounding personnel;

(5) Ensuring environmental control of the compounding areas;

(6) Ensuring that compounded drug preparations maintain quality and sterility until administered or personally furnished;

(7) Ensuring appropriate equipment cleaning and disposal of all hazardous drug waste;

(8) All drug compounding records pursuant to rule 4729:7-3-06 of the Administrative Code;

(9) The proper maintenance, cleanliness, and use of all equipment used in compounding; and

(10) Ensuring aseptic technique for the preparation of all sterile compounded drugs.

(B) A prescriber who compounds or handles hazardous drugs as defined in rule 4729:7-3-01 of the Administrative Code shall meet all of the following requirements:

(1) Policy and procedures

(a) A policy and procedure manual shall be prepared, maintained, and reviewed regularly by the responsible person regarding the compounding, safe handling, personally furnishing, and administration of hazardous drugs. The policy and procedure manual shall include a quality assurance program for the purpose of monitoring personnel qualifications, training and performance, product integrity, equipment, facilities, and guidelines regarding patient education. The policy and procedure manual shall be current and available for inspection and copying by an agent of the state board of pharmacy.

(2) Physical requirements

(a) Sterile compounded hazardous drug preparations shall be compounded within a containment primary engineering control (C-PEC) that meets all of the following requirements:

(i) Provides an ISO class 5 or better air quality, such as a class II or III biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI). Class II BSC types A2, B1 or B2 are acceptable.

(ii) Uses a high-efficiency particulate air filter (HEPA filter) for the exhaust from the control.

(iii) The C-PEC shall be externally vented in a manner where air is not pulled back into the facility by the heating, ventilating, and air conditioning (HVAC) systems or by the windows, doors, or other points of entry. Fans shall be placed downstream of the HEPA filter so that contaminated ducts are maintained under negative pressure.

(iv) Paragraph (B)(2)(a)(iii) of this rule is effective December 1, 2020 or upon any new construction or substantial modifications to the C-PEC or containment secondary engineering control (C-SEC), whichever is earlier. The board may grant a prescriber an extension of the external venting requirements if the board determines, upon petition by the prescriber, that the prescriber is unable to make any structural modifications due to an existing building lease agreement. Any prescriber granted an extension shall provide to the board documentation demonstrating how the prescriber will meet the external venting requirements of this rule by the extension date approved by the board.

(b) Non-sterile hazardous drug preparations shall be compounded in a C-PEC that is either externally vented or has redundant-HEPA filters in series. Nonsterile hazardous compounding must be performed in a C-PEC that provides personnel and environmental protection, such as a "Class I Biological Safety Cabinet (BSC)" or "Containment Ventilated Enclosure" (CVE). A class II BSC or a compounding aseptic containment isolator (CACI) may also be used. For occasional nonsterile hazardous drug compounding, a C-PEC used for sterile compounding may be used but must be decontaminated, cleaned, and disinfected before resuming sterile compounding in that C-PEC. A C-PEC used only for nonsterile compounding does not need to have unidirectional airflow.

(c) C-PECs used for hazardous drug compounding shall be located in a containment secondary engineering control (C-SEC). The C-SEC shall be one of the following:

(i) For non-sterile hazardous drugs and sterile hazardous compounded drugs with a beyond-use date that does not exceed twelve hours, an unclassified containment segregated compounding area (C-SCA) that meets all of the following:

(a) Isolated from other areas and must be designed to avoid unnecessary traffic and airflow disturbances from activity within the controlled area.

(b) Be of sufficient size to accommodate the containment primary engineering control and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.

(c) If the C-PECs used for sterile and nonsterile compounding are placed in the C-SCA, they must be placed at least three feet apart and particle-generating activity must not be performed when sterile compounding is in process.

(d) Has a sink or wash station available for hand washing as well as emergency access to water for removal of hazardous substances from eyes and skin.

(ii) For sterile hazardous compounded drugs with a beyond-use date that exceeds twelve hours, a containment secondary engineering control in accordance with the United States Pharmacopeia Chapter <800>.

(d) A C-PEC and C-SEC used for the preparation of hazardous drugs shall not be used for the preparation of a non-hazardous drug.

(e) The facility shall maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products.

(f) The facility shall have sufficient current reference materials related to sterile preparations to meet the needs of the facility staff.

(3) Environmental quality and control

(a) Environmental wipe sampling to detect hazardous drug surface residue should be performed routinely (e.g., initially as a benchmark and at least every six months, or more often as needed, to verify containment). Common hazardous drug markers that can be assayed include cyclophosphamide, ifosfamide, methotrexate, fluorouracil and platinum-containing drugs.

(b) Surface wipe sampling should include:

(i) Interior of the C-PEC and equipment contained in it;

(ii) Staging or work areas near the C-PEC;

(iii) Areas adjacent to C-PECs (e.g., floors directly under staging and dispensing area);

(iv) Patient administration areas;

(v) Counters where finished preparations are placed.

(c) If any measurable contamination is found, the responsible person shall identify, document, and contain the cause of contamination. The facility shall perform thorough deactivation (using an appropriate deactivating agent), decontamination, and cleaning. The facility shall also consider, at a minimum, the following steps to prevent further contamination:

(i) Reevaluating work practices;

(ii) Re-training personnel; and

(iii) Improving engineering controls.

(4) Personal protective equipment (PPE) and safety techniques

(a) PPE includes, but is not limited to, gloves, gowns, head covers, hair covers, shoe covers, eye/face protection.

(i) Gloves, gowns, head, hair, and shoe covers (or dedicated shoes) are required for compounding sterile and nonsterile hazardous drugs.

(ii) Chemotherapy gloves are required for compounding, handling and administering hazardous drugs. Sterile chemotherapy gloves are required for compounding of sterile hazardous drugs. Personnel should use double gloving for all activities involving hazardous drugs making sure that the outer glove extends over the cuff of the gown.

(iii) Gowns are required when compounding, handling and administering injectable antineoplastic hazardous drugs.

(iv) For all other activities, the facility's policy and procedure manual must describe the appropriate PPE to be worn. The facility must develop policies and procedures for PPE based on the risk exposure and activities performed. Appropriate PPE must be worn handling hazardous drugs during the following:

(a) Receipt;

(b) Storage;

(d) Compounding;

(e) Administration;

(f) Deactivation or decontamination, cleaning, and disinfecting; and

(g) Spill control.

(v) Chemotherapy gloves must be tested to ASTM standard D6978 (or its successor) and must be powder-free. Gloves must be inspected for physical defects before use and must be changed every thirty minutes or when torn, punctured, or contaminated.

(b) All personnel handling hazardous drugs or hazardous drug waste shall wash hands with soap and water before donning protective gloves and immediately after removal.

(c) Disposable gowns shall be tested and shown to resist permeability by hazardous drugs. Gowns shall close in the back (i.e., no open front), be long sleeved, and have closed cuffs that are elastic or knit. Gowns shall not have seams or closures that could allow hazardous drugs to pass through. Cloth laboratory coats, surgical scrubs, isolation gowns, or other absorbent materials shall not be worn as outerwear when handling hazardous drugs. Gowns shall be changed per the manufacturer's information for permeation of the gown. If no permeation information is available for the gowns used, they shall be changed every two to three hours or immediately after a spill or splash. Gowns worn in hazardous drug handling areas shall not be worn to other areas.

(d) Appropriate eye and face protection must be worn when there is a risk for spills or splashes of hazardous drugs or hazardous drug waste materials (examples include, but are not limited to: administration in a surgical suite, cleaning the C-PEC, working at or above eye level or cleaning a spill). A full-face piece respirator provides eye and face protection. Goggles shall be used when eye protection is needed. Eye glasses alone or safety glasses with side shields do not protect the eyes adequately from splashes. Face shields in combination with goggles provide a full range of protection against splashes to the face and eyes. Face shields alone do not provide full eye and face protection.

(e) When a hazardous drug preparation is completed, personnel shall:

(i) Seal the final product in a plastic bag or other sealed container for transport before taking it out of the C-PEC.

(ii) Seal and wipe all waste containers inside the C-PEC before removing them from the cabinet.

(f) When the dosage form allows, hazardous drugs shall be administered using a drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside of the system.

(g) Hazardous drugs shall be administered safely using protective techniques, including the spiking or priming of IV tubing in the C-PEC and crushing hazardous tablets in plastic sleeves.

(5) Respiratory protection

Personnel shall use an appropriately fitted national institute for occupational safety approved N95 or equivalent respiratory protection during spill cleanup and whenever there is a significant risk of inhalation exposure to hazardous drug particulates. Surgical masks do not provide respiratory protection from drug exposure and shall not be used.

(6) Disposal of used personal protective equipment (PPE)

All personal protective equipment worn when handling hazardous drugs shall be placed in an appropriate waste container and further disposed of per local, state, and federal regulations. PPE used during compounding should be disposed of in the proper waste container before leaving the C-SEC. Gloves worn during compounding shall be carefully removed and discarded immediately in an approved hazardous waste container inside the C-PEC or contained in a sealable bag for discarding outside the C-PEC. Potentially contaminated clothing shall not be taken home under any circumstances.

(7) Personnel training

(a) All personnel who handle hazardous drugs shall be fully trained based on their job functions (e.g., in the receipt, storage, handling, compounding, dispensing, and disposal of hazardous drugs). Training shall occur before the employee independently handles hazardous drugs. The effectiveness of training for hazardous drugs handling competencies must be demonstrated by each employee. Personnel competency must be reassessed at least every twelve months and when a new hazardous drug or new equipment is used or a new or significant change in process or standard operating procedure occurs. All training and competency assessment must be documented. The training must include at least the following:

(i) Review of the entity's policies and procedures related to handling of hazardous drugs;

(ii) Proper use of PPE;

(iii) Proper use of equipment and devices (e.g., engineering controls); and

(iv) Spill management.

(b) Compounding personnel of reproductive capability shall confirm in writing that they understand the risks of handling hazardous drugs.

(c) Personnel who handle hazardous drugs shall be reminded that they should undergo medical examinations annually to update their medical, reproductive, and exposure histories. The examinations should be complete, but the skin, mucous membranes, cardiopulmonary and lymphatic systems, and liver should be emphasized.

(8) Facilities

Access to areas where hazardous drugs are unpacked, stored and prepared shall be restricted to authorized staff to protect persons not involved in hazardous drug handling. The location of the hazardous drug compounding area shall be located away from break rooms and refreshment areas for staff, patients, or visitors to reduce risk of exposure. Signs designating the hazard shall be prominently displayed before entry into the hazardous drug area.

(9) Receipt of hazardous drugs

Appropriate PPE shall be used when unpacking hazardous drugs from their shipping containers.

(10) Storage of hazardous drugs

(a) Hazardous drugs shall be stored in a manner that prevents spillage or breakage if the container falls. Hazardous drugs shall not be stored on the floor.

(b) Hazardous drugs shall be stored separately from other inventory.

(11) Decontamination, deactivation, cleaning and disinfection

All areas where hazardous drugs are handled (including during receiving, storage, compounding, transport, administering, and disposal) and all reusable equipment and devices (e.g., C-PEC, carts, and trays) shall be routinely deactivated (using an appropriate deactivating agent for the type of hazardous drugs compounded), decontaminated and cleaned. Additionally, sterile compounding areas and devices must be subsequently disinfected. Equipment used to perform deactivation, cleaning, and disinfection shall not be used in areas where hazardous drugs are not handled. The facility shall establish written procedures for decontamination, deactivation, cleaning, and disinfection (for sterile compounding areas).

(12) Spill control

(a) All personnel who may be required to clean-up a spill of hazardous drugs shall receive proper training in spill management and the use of PPE. Spills shall be contained and cleaned immediately only by qualified personnel with appropriate PPE. Qualified personnel must be available at all times in facilities handling hazardous drugs. Signs must be available for restricting access to the spill area. Spill kits containing all of the materials needed to clean hazardous drug spills shall be readily available in all areas where hazardous drugs are routinely handled. If hazardous drugs are being prepared or administered in a non-routine healthcare area, a spill kit and respirator shall be available. All spill materials shall be disposed of as hazardous waste.

(b) Personnel who are potentially exposed during the spill or spill clean-up or who have direct skin or eye contact with hazardous drugs require immediate evaluation by a health care professional. Non-employees exposed to a hazardous drug spill should report to the designated emergency service for initial evaluation.

(c) An eyewash station and other emergency or safety precautions that meet applicable laws and regulations must be readily available.

(13) Disposal

(a) Disposal of all hazardous drug waste (including unused and unusable hazardous drugs) must comply with all applicable federal, state, and local regulations. All personnel who perform routine custodial waste removal and cleaning activities in hazardous drug handling areas must be trained in appropriate procedures to protect themselves and the environment to prevent hazardous drug contamination.

(b) All syringes and needles used in the course of preparation shall be placed in appropriate hazardous waste containers for hazardous disposal without being crushed or clipped.

(14) Maintenance personnel

Personnel that are charged with cleaning the facility shall wear the appropriate personal protective equipment, including appropriate use of gloves or gowns if they handle linens, feces or urine from patients who have received hazardous drugs within the last forty-eight hours. Appropriate eye and face protection shall be worn if splashing is possible.

(15) Patient training

Whenever possible, a licensed health care provider shall be involved in discussing with each patient receiving a hazardous compounded drug, or the caregiver of such individual, the following matters:

(a) Dosage form, dosage, route of administration, and duration of drug therapy;

(b) Special directions and precautions for preparation and administration; and

(16) Quality assurance

(a) There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, finished compounded drug preparations, and facilities. At a minimum, there shall be written quality assurance programs developed that address:

(i) Adequate training and continuing competency monitoring, including an initial skills assessment and examination as well as annual assessments, of compounding personnel in all of the following areas:

(a) Personal cleansing including proficiency of proper hand hygiene;

(b) Proper attire;

(d) Proper clean room conduct; and

(e) Clean room disinfecting procedures.

(ii) Continued verification of compounding accuracy including physical inspection of end products.

(iii) Continued verification of automated compounding devices.

(iv) End product testing including, but not limited to, the appropriate sampling of products if microbial contamination is suspected.

(b) Instructors shall have the appropriate knowledge and experience necessary to conduct the training.

(c) All clean rooms and other primary engineering devices shall have environmental monitoring performed at least every six months to certify operational efficiency. There shall be a plan in place for immediate corrective action if operational efficiency is not certified. Records certifying operational efficiency shall be maintained for at least three years and shall be readily retrievable.

(17) Packaging and transport

(a) Compounding personnel must select and use packaging containers and materials that will maintain physical integrity, stability, and sterility (if needed) of the hazardous drugs during transport. Packaging materials must protect the hazardous drug from damage, leakage, contamination, and degradation, while protecting healthcare workers who transport hazardous drugs. The entity shall have written standard operating procedures to describe appropriate shipping containers and insulating materials, based on information from product specifications, vendors, mode of transport, and experience of the compounding personnel.

(b) Hazardous drugs that need to be transported must be labeled, stored, and handled in accordance with applicable federal, state, and local regulations. Hazardous drugs must be transported in containers that minimize the risk of breakage or leakage. Pneumatic tubes must not be used to transport any liquid or antineoplastic hazardous drugs because of the potential for breakage and contamination.

(D) A hazardous compounded drug that is personally furnished by a prescriber must be labeled according to rule 4729:5-19-02 of the Administrative Code and must include the appropriate beyond-use date, in accordance with United States Pharmacopeia Chapter <797> or <795> and complete list of ingredients. The statement "Hazardous Compounded Drug" shall also be displayed prominently on the label.

(E) A prescriber shall not compound hazardous drugs in anticipation of prescriptions based on routine prescribing patterns.

(F) A prescriber is required to perform medication validation ("final check") of the finished hazardous compounded drug preparation prior to it being administered to a patient.

(G) Paragraph (F) of this rule does not apply if a hazardous compounded drug is being administered to a patient in the facility by a nurse licensed under Chapter 4723. of the Revised Code in accordance with their applicable scope of practice pursuant to a prescriber's order and, prior to administration, at least two nurses that are approved by the responsible person to prepare or administer compounded drugs comply with the following:

(1) Verify patient identification using at least two identifiers (e.g., last name, medical record number, DOB, etc.).

(2) Confirm with the patient the patient's planned treatment, drug route, and symptom management.

(3) Verify the accuracy of the following:

(a) Drug name;

(b) Drug dose;

(d) Rate of administration;

(e) Route of administration;

(f) Expiration dates/times; and

(g) Appearance and physical integrity of the drugs.

(4) Indicate in the compounding record verification was completed.

(5) Extravasation management procedures are defined.

(6) Antidote order sets and antidotes are accessible.

(7) A prescriber is on-site and immediately available.

(H) A prescriber may designate an appropriately trained agent to assist the prescriber in the compounding of hazardous drugs.

(I) For non-sterile hazardous compounded drugs, the prescriber shall also comply with United States Pharmacopeia Chapter <795>.

(J) Sterile hazardous compounded drugs prepared with beyond-use dates greater than twelve hours, shall comply with beyond-use dating requirements in accordance with United States Pharmacopeia Chapter <797>.

History

Effective: March 31, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:7-3-06

(A) The responsible person shall maintain the following records relating to the compounding of dangerous drugs:

(1) All drug orders and records, including logs, relating to the compounding of drugs. Such drug orders and records may be retained by any process providing an exact duplicate of the original order or prescription.

(2) 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:

(a) Complies with the requirements of this rule;

(b) All paper records shall be scanned in full color via technology designed to capture information and reproduce it in an electronic medium presentable and usable to an end user;

(d) Contains daily back-up functionality to protect against record loss.

(3) Records of each drug compounded shall, at a minimum, include all the following:

(a) The full name of the patient, unless compounded in accordance with paragraph (G)(2) of rule 4729:7-3-04 of the Administrative Code;

(b) Name, strength, and dosage form of the compounded drug;

(d) If a controlled substance, the disposition of unused drug(s) and amount;

(e) Date and time of preparation;

(f) Beyond-use date of the compounded drug;

(g) The positive identification of the personnel responsible for compounding the drug;

(h) The positive identification of either of the following:

(i) Person or persons performing medication validation prior to the compounded drug being administered; or

(ii) The prescriber personally furnishing the compounded drug.

(B) Records of disposal of compounded drugs, 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 identification of the licensed health care professional that performed the disposal.

(C) Records of the disposal of compounded drugs containing controlled substances shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of a compounded drug containing a controlled substance 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 the responsible person or the responsible person's designee.

(2) If conducting the disposal of an unused portion of a compounded drug containing 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.

(3) A veterinarian may use an animal aide, as defined in section 4741.01 of the Revised Code, in lieu of one of the licensed or registered healthcare professionals required to witness and conduct the disposal of controlled substances pursuant to paragraphs (C)(1) and (C)(2) of this rule. Records kept in accordance with paragraphs (C)(1) and (C)(2) of this rule shall include the positive identification of the animal aide witnessing the disposal.

(D) Drug compounding records which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this rule.

(E) 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.

History

Effective: March 31, 2021
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-19-02

(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 4729:5-3-01

(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 4729:7-3-07 Pharmacists conducting medication validation.

(A) Notwithstanding any provision of this chapter of the Administrative Code, a prescriber may delegate a pharmacist to perform medication validation ("final check") of a finished compounded drug preparation prior to it being administered to a patient.

(B) A pharmacist performing medication validation in accordance with paragraph (A) of this rule shall comply with the record keeping provisions of rule 4729:7-3-06 of the Administrative Code.

Last updated November 16, 2023 at 8:40 AM

History

Effective: November 16, 2023
Promulgated Under: 119.03

Ohio Administrative Code 4729:7 — State Board of Pharmacy | Drug Compounding

Chapter 4729:7-1 Compounding References

Ohio Adm.Code 4729:7-1-01 Compounding references.

Chapter 4729:7-2 Pharmacy Compounding

Ohio Adm.Code 4729:7-2-01 Definitions - pharmacy compounding.

Ohio Adm.Code 4729:7-2-02

Ohio Adm.Code 4729:7-1-01

Ohio Adm.Code 4729:7-2-03 Drugs compounded in a pharmacy.

Ohio Adm.Code 4729:7-2-04

Ohio Adm.Code 4729:5-5-06

Ohio Adm.Code 4729:7-2-05 Drugs compounded for veterinarian office use.

Ohio Adm.Code 4729:5-8-04

Ohio Adm.Code 4729:5-3-09

Chapter 4729:7-3 Prescriber Compounding

Ohio Adm.Code 4729:7-3-01 Definitions - prescriber compounding.

Ohio Adm.Code 4729:7-1-01

Ohio Adm.Code 4729:7-3-04

Ohio Adm.Code 4729:7-3-02 Exemptions.

Ohio Adm.Code 4729:7-3-03 Non-Hazardous Drugs Compounded by a Prescriber.

Ohio Adm.Code 4729:7-3-05

Ohio Adm.Code 4729:7-3-06

Ohio Adm.Code 4729:5-19-02

Ohio Adm.Code 4729:5-3-01

Ohio Adm.Code 4729:7-3-07 Pharmacists conducting medication validation.

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