Chapter 4729:7-2 | Pharmacy Compounding

Rule 4729:7-2-01 | Definitions - pharmacy compounding.

• Effective: July 1, 2021
• Promulgated Under: 119.03

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;

(c) A bar code 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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.01
Five Year Review Date: 7/1/2026
Prior Effective Dates: 10/24/2014, 4/1/2017

Rule 4729:7-2-02 | Sterile compounding exemptions.

• Effective: July 1, 2021
• Promulgated Under: 119.03

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

Supplemental Information

Authorized By: 4729.26, 3715.69, 3719.28
Amplifies: 3715.521, 3715.63, 3715.64, 3719.05, 4729.28, 4729.55
Five Year Review Date: 7/1/2026

Rule 4729:7-2-03 | Drugs compounded in a pharmacy.

• Effective: March 7, 2024
• Promulgated Under: 119.03

(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 March 7, 2024 at 9:37 AM

Supplemental Information

Authorized By: 4729.26, 3715.69, 3719.28
Amplifies: 3715.521, 3715.63, 3715.64, 3719.05, 4729.28, 4729.55
Five Year Review Date: 3/7/2029
Prior Effective Dates: 2/15/2016

Rule 4729:7-2-04 | Record keeping.

• Effective: July 1, 2021
• Promulgated Under: 119.03

(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

(c) The pharmacist who dispenses the compounded drug preparation.

(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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.541, 4729.55, 3719.07, 4729.37
Five Year Review Date: 7/1/2026
Prior Effective Dates: 5/1/2015

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

• Effective: July 1, 2021
• Promulgated Under: 119.03

(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

(c) For diagnostic purposes.

(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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.55, 4729.01, 4729.54, 4729.541
Five Year Review Date: 7/1/2026
Prior Effective Dates: 2/22/2016