FDA Proposes New Regulations for Animal Drug Labeling

Today the U.S. Food and Drug Administration is proposing new regulations to provide animal drug sponsors with predictable requirements for the labeling of prescription and over-the-counter new animal drugs, as well as new animal drugs for use in animal feeds. The proposed content and format of labeling would also benefit veterinarians, animal owners, and animal producers by providing a more consistent presentation of information on the safe and effective use of these new animal drugs.

The FDA has long followed certain practices for reviewing animal drug labeling, but these have not been codified in regulation. If finalized, the rule would create for the first time a comprehensive set of regulations establishing requirements for content and format of the labeling for approved and conditionally approved new animal drugs and would also help animal drug sponsors more efficiently prepare labeling for review.

You are subscribed to updates from FDA's Center for Veterinary Medicine.