4729-16-12 Drugs compounded by a pharmacy for use by a veterinarian.

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

(B) For all non-sterile compounded products, the pharmacy shall comply with the United States pharmacopeia chapter <795>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(C) For all sterile compounded products, the pharmacy shall comply with the United States pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto (9/10/2015).

(D) In accordance with applicable federal laws and regulations, a pharmacist working at an pharmacy licensed as a terminal distributor of dangerous drugs may compound and provide without a prescription a non-patient specific 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 the following:

(1) The pharmacy shall only provide compounded drug products that are not commercially available, as defined division (C)(5) of section 4729.01 of the Revised Code, to a veterinarian which are needed:

(a) To treat an emergency situation;

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

(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 that meets the following:

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

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

(c) The pharmacist who provides the veterinarian with a compounded drug 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 to a patient when, in their professional judgment, failure to provide the drug would result in potential harm to the patient.

(F) The pharmacy shall not sell a compounded drug to another pharmacy or wholesaler.

(G) Veterinarians shall not:

(1) Sell a compounded drug to another prescriber;

(2) Sell a compounded drug to a pharmacy; or

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

(H) The labeling of a compounded drug product must contain the following:

(1) Proper storage conditions;

(2) Beyond use dates;

(3) The name(s) of the active and inactive ingredients;

(4) The amount or percentage of active drug ingredients;

(5) The quantity of compounded drug provided;

(6) The route of administration;

(7) The pharmacy name, address, and telephone number;

(8) The pharmacy control number assigned to the compounded drug product.

(9) The statement "Compounded Drug Product" or other similar statement.

(I) Compounded drug product containers that are too small to bear a complete label pursuant to paragraph (H) of this rule must bear a label that contains at least the following information:

(1) The storage conditions if other than room temperature;

(2) The beyond use date;

(3) The drug name(s), including all active ingredients;

(4) The drug strength(s);

(5) The route of administration;

(6) The pharmacy control number;

(7) The pharmacy name.

(J) In all cases, a complete label meeting the requirements of paragraph (H) of this rule must be applied to the outside container in which such compounded drug is supplied.

(K) The sale of a compounded drug product to a prescriber is considered a wholesale sale as defined in section 4729.01 of the Revised Code. A pharmacy is required to follow the record keeping requirements for wholesale sales listed in paragraph (H) of rule 4729-9-16 of the Administrative Code.

(L) A pharmacy shall follow the compounding requirements pursuant to rules 4729-16-03 and 4729-16-06 of the Administrative Code, current professional compounding standards, and all applicable federal and state laws, rules, and regulations.

(M) No pharmacy shall sell any amount of non-patient specific veterinarian administered compounds in excess of five per cent of the total amount of drug products sold and/or dispensed from their pharmacy. The five per cent limitation shall be calculated on an annual basis and shall reference the number of dosage units. For non-resident pharmacies, the total amount sold and/or dispensed shall reference the pharmacy's total business within this state.

Cite as Ohio Admin. Code 4729-16-12

Effective: 2/22/2016
Five Year Review (FYR) Dates: 02/22/2021
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.55, 4729.01, 4729.54, 4729.541