January 15, 2005


 Using veterinary feed directive drugs in an extralabel manner

Posted Jan. 1, 2005

The AVMA Executive Board has referred a position statement regarding the extralabel use of veterinary feed directive drugs for minor species to the AVMA Council on Biologic and Therapeutic Agents. The AVMA Aquatic Veterinary Medicine Committee recommended the statement, which says that veterinarians, their clients, and patients would be well-served if the Food and Drug Administration's Center for Veterinary Medicine amended compliance policy guide 615.115, Extralabel Use of Medicated Feeds for Minor Species, so that it includes veterinary feed directive drugs, in addition to over-the-counter drugs.

Currently, the federal Food, Drug, and Cosmetic Act does not allow the extralabel use of medicated feeds. The agency, however, recently published a compliance policy guide that establishes conditions under which extralabel use of medicated feeds will be permitted in minor species. The CPG addresses extralabel use of OTC medicated feeds, but does not specifically address extralabel use of medicated feeds containing VFD drugs.

While only one VFD drug is currently approved, Pulmotil for control of respiratory disease in swine, the AVMA Aquatic Veterinary Medicine Committee believes it is important for this category of drugs to be available for extralabel use in minor species, especially if more VFD drugs are approved. Extralabel use of drugs is important for minor species, such as cultured fish, because few drugs are approved for these species.

While the board saw merit in the recommendation, they wanted it reviewed by COBTA before making any decision on the matter.