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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter September/October 2001 Volume XVI, No V

The Feed Manufacturing Compliance Program (7371.004) for animal feeds for 2001-2005 has been printed and distributed to FDA offices.

Compliance Programs are formally written plans that 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 Feed Manufacturing 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 the safety of feed ingredients and their impact on public health. Of particular concern is the use of mammalian protein in feed for ruminants because of the possible transmission of the causative agent for Bovine Spongiform Encephalopathy (BSE). BSE is a fatal animal disease that may be linked to a fatal human disease called new variant Creutzfeldt-Jakob Disease. To help prevent the establishment of BSE in the U.S., FDA published regulations (August 4, 1997) prohibiting the use of certain mammalian protein in feed for ruminant animals. This compliance program addresses the inspection of feed manufacturing facilities to assess the firm's compliance with these regulations.

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 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. The VFD is another mandate of the ADAA.

The Feed Manufacturing Compliance Program contains a completely revised Form FDA 2481, Medicated Feeds Inspection Report. The form contains questions that relate to 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.