FDA Issues New Rule for Animal Drugs in Animal Feed (August 2016)

The U.S. Food and Drug Administration (FDA) issued a final rule in response to the enforcement of an antimicrobial resistance strategy they had initiated previously regarding animal feed. In their efforts to monitor the use of antimicrobial drugs in animal agriculture, FDA’s Center for Veterinary Medicine (CVM) published Guidance #213 in 2013 requesting that animal drug sponsors using “medically important” antimicrobials in animal feed retract approval notices from their product labels and instead defer prescriptions to licensed veterinarians. However, some of these antimicrobials approved to be used in feed for “major” animal species (pigs, cattle, chicken) are also approved for remedial use in “minor” species (goats, sheep, fish). FDA intends to refine the basis upon which these approval notices are withdrawn to prevent mishaps that will restrict the production and distribution of remedial minor species drugs in the market.

Once animal drugs are approved to be used in animal feed, they are evaluated based on the potential threat the drug poses to livestock when treating them or in food production. The drugs are then assigned to either Category I or II based on whether or not a withdrawal period is required upon approval. Those placed in Category II will not be allowed to be produced by unlicensed mills, which make up the majority of feed mills in the country. FDA intends to improve these animal drug category definitions to ensure that production of minor species remedial use drugs remains in both licensed and unlicensed feed mills.

FDA is opening a public comment period on the rule for 75 days. Comments may be submitted electronically or by mail.