May 27, 2004
FDA Publishes Final Rules for Liquid and Free-Choice Medicated Feeds
The Food and Drug Administration (FDA) is changing the regulations for liquid medicated feed and free-choice medicated feed. Liquid medicated feed is a physical form of animal feed that contains an approved new animal drug; other feeds may be dry. Free-choice medicated feed is a feeding system where medicated animal feed (dry or liquid) is offered to animals free-choice, that is, animals have access to the feed at any time and consume it at their will.
By changing the regulations for liquid medicated feed, FDA wants to clarify: what data are required to demonstrate chemical and physical stability of a drug in liquid feed, how such data may be submitted for use in the new animal drug approval process, and which liquid medicated feeds will require an approved medicated feed mill license. By changing the regulations for free-choice medicated feed, FDA wants to ensure that they are consistent with the requirements for liquid medicated feed, and that provisions for free-choice medicated feed and liquid medicated feed comply with the terms of the Animal Drug Availability Act (ADAA) of 1996.
The final rule was published in the May 27, 2004 , Federal Register. Single copies of the final rule may be obtained by writing to the Communications Staff , FDA/Center for Veterinary Medicine, 7519 Standish Place , HFV-12, Rockville , MD 20855 . Please send a self-addressed adhesive label to assist in processing your request.
The proposed rule was published in the May 28, 2003 , Federal Register . The final rules for liquid medicated feed and free-choice medicated feeds adopt the proposed rules without change. For both the liquid and free-choice medicated feed final rules, FDA concluded that an approved medicated feed mill license is required for facilities that manufacture feeds using category II drug(s) or manufacture those products using category I drug(s) that must follow proprietary formulas or specifications. This means that c ertain liquid and free-choice medicated feeds will no longer require an approved medicated feed mill license for their manufacture. The final rule will become effective June 28, 2004 .
Additional information is available in the May 27, 2004, Federal Register and from Dr. Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0169, e-mail: dmomcilo@cvm.fda.gov .
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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