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GUIDANCE DOCUMENT

CVM GFI #72 GMP'S For Medicated Feed Manufacturers Not Required to Register and be Licensed with FDA May 1998

Final
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

A most important responsibility of an animal feed manufacturer is to assure that the feed produced--whether medicated or non-medicated--meets the intended specifications and is not adulterated. All feed mixing operations, regardless of size or drugs used, share this responsibility. Medicated feeds must be proper with respect to drug content to have their intended effect. Medicated and non-medicated feeds that are adulterated with undesired drugs may cause violative drug residues in meat, milk or eggs, or injury to consuming animals. Everyone associated with food animal agriculture must work to avoid these risks to the public and animal health, and the potential loss of consumer confidence in animal-derived food products.

The Food and Drug Administration (FDA) established the Current Good Manufacturing Practice (CGMP) Regulations for Medicated Feeds through public rulemaking. The CGMPs 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. The regulations apply equally to all manufacturers of medicated feeds using the same drug sources. The regulations are divided into two sections. The first section applies to facilities utilizing drug sources which require licensing and registration with FDA. This section is more comprehensive and detailed than the second section. The second section applies to those facilities which are not required to be licensed and registered. Medicated feeds must be manufactured in accordance with the appropriate applicable section of the CGMP Regulations to comply with the law.

This guide is designed to provide information and answer typical questions about the regulatory responsibilities of the manufacturers of medicated feeds who are not licensed and registered with FDA and, hence, are subject to the requirements of the less detailed CGMP Regulations.


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

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