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U.S. Department of Health and Human Services

Animal & Veterinary

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CPG Available on Compounding of Drugs for Use in Animals

July 15, 2003

FDA announced the availability of a revised Compliance Policy Guide (CPG) section 608.400 entitled “Compounding of Drugs for Use in Animals” in the July 14, 2003, Federal Register. The purpose of the revised CPG is to ensure that the Agency’s enforcement policy regarding the compounding of drugs intended for use in animals is consistent, to the extent practicable, with its enforcement policy regarding the compounding of drugs intended for use in humans. In addition, FDA is revising its previous animal drug compounding CPG to ensure it is consistent with the current animal drug compounding regulations, which are codified at Title 21, Part 530 of the Code of Federal Regulations. The CPG represents the Agency’s current thinking on the enforcement of the Federal Food, Drug, and Cosmetic Act with regard to drug products compounded for use in animals.

This CPG is intended to provide guidance and instructions to FDA staff, industry, and the public for obtaining information to help fulfill the Agency’s plans regarding the compounding of drugs for use in animals. The CPG does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

A copy of the CPG is available on the FDA Home Page. Individuals who prefer a paper copy may submit written requests for single copies of the CPG to the Director, Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Please send one self-addressed adhesive label to assist in processing the request.

Comments on the CPG may be submitted any time to: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the full title of the CPG and Docket Number 2003D-0290.

Additional information about the CPG may be found in the July 14 Federal Register notice. Technical questions concerning this CPG should be directed to Dr. Neal Bataller, Center for Veterinary Medicine, HFV-230, Food and Drug Administration, 7500 Standish Place, Rm. E441, Rockville, MD 20855, 301-827-0163, nbatalle@cvm.fda.gov.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855