In August 1999 the FDA issued a draft compliance policy guide for FDA personnel on the agency's exercise of regulatory discretion with regard to the extralabel use of medicated feeds for minor species. The document was called "Use of Medicated Feeds for Minor Species."
The agency has reviewed comments about the draft and revised the guidance. In the April 23, 2001 Federal Register, the FDA announced that the new compliance policy guide, "Extra-Label Use of Medicated Feeds for Minor Species," is now available.
The final version differs from the draft in three areas. First, sheep are now considered a minor species for all data collection purposes.
The second change states that the medicated feed must be manufactured and labeled in accordance with the approved conditions of use. This is simply a clarification of existing provisions. In essence, the feed cannot be reformulated so that it would no longer be appropriate for the species for which it is approved.
The third change clarifies the limitations on the agency's intent to exercise regulatory discretion. For use in a food-producing minor species, the medicated feed must be approved in a food-producing major species. The FDA intends to exercise regulatory discretion only for farmed or confined species. With factors in the aquatic environment being so varied, the agency intends to exercise regulatory discretion only for extralabel use of medicated feeds already approved for an aquatic use.
A copy of the compliance policy guide is posted at www.fda.gov/ora. Single copies may be obtained by sending a self-addressed, adhesive label to the Communications Staff (HFV-12), FDA-CVM, 7500 Standish Place, Rockville, MD 20855. More information is available from Frances M. Pell, FDA-CVM (HFV-235), 7500 Standish Place, Rockville, MD 20855; phone, (301) 827-0188; firstname.lastname@example.org.
As with all its guidance documents, the FDA encourages the public to submit written comments with new data or other pertinent new information. Send to the Dockets Management Branch (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.