Code of Maine Rules
02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION
392 - MAINE BOARD OF PHARMACY
Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE
Chapter 42 - Compounding Drugs for Veterinarian Office Use
Section 392-42-3 - GENERAL REQUIREMENTS FOR COMPOUNDING DRUGS FOR VETERINARIAN OFFICE USE

Current through 2024-38, September 18, 2024

1. Content of drug orders. The drug order shall include the name, address and telephone number of the licensed veterinarian;

2. The pharmacy must inform the veterinarian that:

A. The compounded drug is being provided for veterinarian office use only;

B. The compounded drug will only be dispensed or administered to nonfood-producing animals that are patients of the veterinarian with a valid veterinarian-client-patient relationship;

C. The compounded drug will only be dispensed or administered for the treatment of emergency conditions or urgent situations, when, as determined by the prescribing veterinarian, urgent treatment is needed to avoid animal suffering or death and there is no timely access to a compounding pharmacy to compound and dispense the drug under a patient-specific prescription;

D. The quantity of the compounded drug dispensed by a prescribing veterinarian will not exceed a 336-hour supply (14-day) or the smallest uniform manufactured size sufficient to treat the condition; and

E. The prescribing veterinarian will provide instructions to owners to contact the prescribing veterinarian immediately if a compounded preparation has caused an adverse event or the owner suspects a defective drug product, and the veterinarian will report this information to the compounding pharmacy and the U.S. Food and Drug Administration Center for Veterinary Medicine.

3. Verification. The pharmacist who receives an order for compounded drugs for veterinarian office use shall record the order and verify the identity of the licensed veterinarian, and, if applicable, the identity and authority of the veterinarian's agent.

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