May 28, 1998
FDA GUIDANCE FOR NON-REGISTERED FEED MANUFACTURERS AVAILABLE
FDA's Center for Veterinary Medicine (CVM) has released a revised guide intended to help manufacturers of medicated feed that are not required to register with the FDA comply with the Current Good Manufacturing Practice (CGMP) regulations, 21 CFR 225.120 - 225.202.
The revised guide is titled "Guidance for Industry -- GMP's for Medicated Feed Manufacturers Not Required to Register and Be Licensed with FDA" (Guidance Document 72). It is a revised version of the 1989 publication "GMPs for Medicated Feed Manufacturers Not Required to Register with FDA."
The Animal Drug Availability Act (ADAA) of 1996 established feed mill licensing as a replacement for FDA's previous medicated feed application (MFA) system. Those manufacturers that are exempted from registration and licensing include those that manufacture only Type B or Type C medicated feeds using: (1) Category I drugs as Type A medicated articles or Type B or C medicated feed, and/or (2) Category II drugs as Type B or C medicated feed.
The CGMPs were established to provide guidance for medicated feed manufacturers to assure that their products meet the identity, strength and quality which they should possess with respect to their drug content. These regulations apply equally to all manufacturers of medicated feeds with more stringent regulations for licensed facilities and a less stringent set for facilities that are not required to be licensed by FDA. This guide is designed to provide information and answer typical questions about the regulatory responsibilities for those feed manufacturers that are not licensed and registered with FDA.
The guide is available through the CVM Internet Home Page or by calling the CVM Communications Staff at 301-594-1755. Additional information regarding this document may be obtained by contacting CVM's Division of Animal Feeds, Dr. George Graber, 7500 Standish Place, HFV-220, Rockville, MD 20855, 301-827-6651.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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