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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter September/October 2000 Volume XV, No. V

By Patsy Gardner

The Division of Animal Feeds has published a revised compliance program for animal feeds. The program has undergone a complete rewrite, and now carries a new name, the Feed Manufacturing Compliance Program (7371.004).

Compliance Programs are formally written plans which direct and specify the work that is done by the FDA=s field personnel. They generally provide specific guidance to ensure a uniform approach for regulatory/administrative action; to accumulate data on a known problem to determine long-range trends on a statistically valid basis; and to gather product or industry information within a specific time frame to determine the existence or extent of a problem.

In the past the Medicated Feeds Compliance Program has been limited to medicated feed manufacturing. The name was changed to incorporate inspectional and regulatory coverage for non-medicated and medicated feed manufacturing as needed. This change was in response to the growing concern over feed ingredients and their impact on public health.

The enactment of the Animal Drug Availability Act of 1996 (ADAA) amended Section 512 (m) of the Federal Food, Drug, and Cosmetic Act to require a single facility license rather than multiple medicated feed mill applications (MFAs) for each feed mill as previously required. Firms using Category II Type A Medicated Articles to make medicated feeds are required to register with FDA and hold an approved medicated feed mill license. The compliance program contains information on the Medicated Feed Mill License as well as guidance on the current good manufacturing practice regulations; it also contains a list of definitions for terms used in it. The Program also contains information on verifying compliance with Veterinary Feed Directive (VFD) requirements and information for those who wish to distribute feed containing VFD drugs.

Because of the concern with the use of mammalian protein in feed for ruminants and the possible transmission of the causative agent for Bovine Spongiform Encephalopathy (BSE), the program contains information on assessing a firm's compliance with 21 CFR 589.2000.

The Feed Manufacturing Compliance Program contains a completely revised Form FDA 2481, Medicated Feeds Inspection Report. The form contains questions that relate to 21 CFR 225, BSE, and VFDs.

For a copy of the revised program, please contact Patsy Gardner at 301-827-0187, or by e-mail at pgardner@cvm.fda.gov.

Patsy Gardner is an Industry Compliance Analyst in CVM’s Division of Animal Feeds.