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. According to the agency, 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.

The FDA is also proposing to amend or remove certain current regulations to ensure consistency with the proposed new regulations. This would place all the labeling requirements regarding the content and format of approved or conditionally approved new animal drugs in one location in the Code of Federal Regulations. If the proposed regulations are finalized, existing labeling-related guidances for approved and/or conditionally approved new animal drugs would be amended or removed as appropriate to be compliant with the final regulations.

The FDA is accepting public comments on the proposed rule for 90 days from the date of publication in the Federal Register. The public should submit either electronic or written comments on the proposed rule by June 10, 2024, to ensure that the Agency considers your comments on this proposed rule before it begins work on the final version of the rule.

Comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2023-N-5160 for “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs.”

If finalized, future new animal drug applications would need to comply with these proposed regulations. Sponsors of previously approved new animal drugs would need to comply with these proposed regulations on a staggered schedule, over the course of 6 years, according to a schedule based on application number.