Current through Vol. 42, No. 1, September 16, 2024
(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 dispense or transfer
compounded medications to:
(1) the Owner or
caretaker of animal patient, or
(2)
a veterinarian within the same practice.
Added at 17 Ok Reg
2633, eff 7-1-00; Amended at 26 Ok Reg 2276, eff
7-1-09
