Draft CPG on Use of Medicated Feeds for Minor Species Available

The following is a reminder on request for public comments on FDA-CVM's Draft Compliance Policy Guide (CPG) on use of medicated feeds for minor species. This issue is of particular importance to aquaculture industry as oral administration of antibiotics is normal route of administration.  Please share this notice with others and note deadline for comments by November 23, 1999. This draft CPG helps clarify the conditions of use of extra-label medicated feed for fish after passage of AMDUCA that specifically prohibited extra-label use of drugs in or on feed. Your comments are requested. Visit FDA home page for copy of complete Federal Register notice or contact FDA.

August 26, 1999

FDA announced in the August 25, 1999, Federal Register, the availability of a draft Compliance Policy Guide (CPG) entitled "Use of Medicated Feeds for Minor Species.'' The purpose of the draft CPG, if finalized, would be to provide guidance to FDA's field offices concerning the Agency's exercise of regulatory discretion with regard to the extra-label use of medicated feeds for minor species. This draft CPG is being made available for comment only.

Copies of this draft guidance document may be obtained from the FDA Home Page, or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Prior to 1994, the Federal Food, Drug, and Cosmetic Act (the Act) did not permit extra-label use of animal drugs, but FDA exercised regulatory discretion regarding extra-label use of animal drugs provided certain criteria were met. These criteria were published in a CPG and were largely incorporated into the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA). AMDUCA amended the Act to permit extra-label uses under certain conditions. AMDUCA did not permit extra-label use of
medicated feeds. However, there are some minor species that cannot be practically medicated in any way other than through the use of medicated feeds. Furthermore, minor species such as fish and game birds have very few drugs approved for their use. In such situations, a veterinarian may determine that extra-label use of medicated feeds approved for use in other species can prevent suffering and death in these minor species.

Before the implementation of AMDUCA, the Agency occasionally exercised regulatory discretion for extra-label use of medicated feeds for minor species based on a medical need as long as the medicated feeds were formulated and labeled in accordance with their approved application. Because AMDUCA did not permit extra-label use of medicated feeds, FDA is considering providing this guidance document to our field personnel to use when such extra-label use is encountered.

Interested persons may submit written comments on the draft guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, by November 23, 1999. Comments should be identified with the full title of the draft guidance document and docket number 99D-2638.

Further information about this document is contained in the August 25, 1999, Federal Register notice, and from Judy A. Gushee, Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0150, e-mail
"jgushee@cvm.fda.gov".