New labeling regulations proposed by FDA for animal drugs


The Proposed Rule aims to improve content submission and format consistency

drug labeling

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Labeling regulations that would help provide animal drug sponsors with predictable requirements for the content and format of prescription and over-the-counter new animal drugs, as well as drugs used in animal feed, were proposed today by the FDA. The agency aims to provide consistent presentation of information for safe and effective use of animals drugs through these proposed regulations. The regulation would help sponsors more efficiently prepare labeling for review, while also benefiting veterinarians, animal owners, and animal producers.1

Multiple components make up a label for new prescription animal drugs including package inserts, secondary container labeling, shipping information, multiple unit carton labeling or display carton labeling, according to the FDA. Currently, a label’s format and the order the information appears are not regulated. Based on feedback compiled over the past 60 years, officials with the FDA have determined that drug sponsors could benefit from more detailed requirements, which would better allow them to prepare adequate labeling.2

“The lack of direction regarding format and content for each component of labeling has resulted in confusion for sponsors as they prepare labeling for FDA’s review and sometimes results in poor quality labeling submissions. Poor quality labeling submissions increase the time needed by sponsors to revise and resubmit adequate labeling, and they increase the time needed by FDA to review and approve labeling, and consequently, the application,” agency officials wrote in the unpublished Proposed Rule filed today.2

Although the FDA has long followed certain review practices for animal drug labeling, they have not been organized in regulation. The Proposed Rule aims to create a comprehensive set of regulations that establish requirements for content and format of the labeling for new animal drugs including approved and conditionally approved products, according to the agency.1

The FDA is also proposing to amend or remove certain current regulations to ensure consistency with the proposed new regulations. The action would place all labeling requirements for content and format of approved or conditionally approved new animal drugs in a single location in the Code of Federal Regulations. Under the proposed regulations, existing labeling-related guidance for approved and/or conditionally approved new animal drugs would be amended or removed as appropriate for compliance.1

If finalized, future new animal drug applications would need to comply with the 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.1

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, for consideration by the agency before it begins work on the final version.1

Comments can be submitted electronically through 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.”1


  1. FDA proposes new regulations for animal drug labeling. News release. FDA. March 8, 2024. Accessed March 8, 2024.
  2. Califf RM. Proposed rule: labeling requirements for approved or conditionally approved new animal drugs. FDA and US Department of Health and Human Services. March 1, 2024. Accessed March 8, 2024.
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