Rule 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
(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