02-392-42 Me. Code R. § 4

Current through 2024-51, December 18, 2024

Section 392-42-4 - LABELING REQUIREMENTS

Compounding drugs for veterinarian office use shall be labeled in a conspicuous and legible manner, as appropriate for the size and attributes of the container.

The label shall include:

1. Pharmacy name, address, and telephone number;

2. Date of distribution;

3. Name, address, and telephone number of the licensed veterinarian who placed the order;

4. The name and strength of the compounded preparation or a list of the active ingredients and the strength of the active ingredients in the compounded preparation;

5. The quantity of compounded preparations;

6. Cautionary statements if appropriate for the drug;

7. An appropriate beyond-use date as determined by the pharmacist in compliance with United States Pharmacopeia and the National Formulary (USP-NF) standards for pharmacy compounding; and,

8. Text to read as follows:

"Compounded for Veterinary Office Use Only. Intended only for dispensing and administration for nonfood-producing animals as determined by the prescribing veterinarian."

02-392 C.M.R. ch. 42, § 4