Okla. Admin. Code § 535:15-10-64.1

Current through Vol. 42, No. 7, December 16, 2024

Section 535:15-10-64.1 - Compounding veterinarian sterile preparations

(a) Prescriptions for animals may be compounded based on an order or prescription from a licensed prescriber.

(b) Compounded preparations must comply with federal statutes, rules and FDA guidance.

(c) Caution should be taken as to not violate federal patent laws by duplicating an available product in inordinate quantities.

(d) Compounding with bulk chemicals for food-producing animals is not permitted.

(e) It is acceptable for any licensed pharmacy to compound animal drugs from bulk substances for office use without patient-specific prescriptions for nonfood-producing animals if:

(1) The drug is compounded by or under the direct supervision of a pharmacist in a state-licensed pharmacy or a federal facility,

(2) The drug is intended for use in a nonfood-producing species and is compounded from a bulk drug substance listed on FDA's "List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals",

(3) The drug is compounded in full compliance with state laws and regulations governing drugs, pharmacy, and veterinary medicine. All bulk drug substances, inactive ingredients, and finished drug products used in compounding meet the standards set in any applicable USP-NF monograph and comply with other FD&C Act requirements for drug components,

(4) Upon becoming aware of any adverse event or product defect associated with an animal drug compounded from a bulk drug substance, the pharmacist that compounded the drug reports the event on Form FDA 1932a within 15 business days, and

(5) The labeling of the compounded drug includes all the following:

(A) Name of drug,

(B) Strength of drug,

(C) Species of the patient(s) and indication(s) for which the drug will be used,

(D) Name, address, and contact information for the compounding pharmacy,

(E) BUD,

(F) The statement, "Report suspected adverse reactions to the [pharmacist who compounded the drug] and to the FDA using online Form 1932a",

(G) The statement, "This is a compounded drug. Not an FDA approved or indexed drug.",

(H) The statement, "Not for use in food-producing animals", and

(I) The statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

(f) Veterinarians may transfer compounded medications to:

(1) the Owner or caretaker of animal patient, or

(2) a veterinarian within the same practice.

Okla. Admin. Code § 535:15-10-64.1

Adopted by Oklahoma Register, Volume 35, Issue 24, September 4, 2018, eff. 9/14/2018

Amended by Oklahoma Register, Volume 40, Issue 22, August 1, 2023, eff. 9/1/2023