2024-04840: Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Summary

The Food and Drug Administration (FDA) is proposing to revise the requirements for the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of requirements in one location in the Code of the Federal Register (CFR). As part of this revision, certain current requirements would be updated and moved, and certain obsolete requirements would be removed. The proposed requirements would apply to the labeling of prescription and over-the-counter (OTC) new animal drugs, as well as new animal drugs for use in animal feeds.

The agency’s own summary, as published.

What this changes

Amends 6 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 201 Labeling
• 21 CFR 500 General
• 21 CFR 501 Animal Food Labeling
• 21 CFR 510 New Animal Drugs
• 21 CFR 514 New Animal Drug Applications
• 21 CFR 516 New Animal Drugs for Minor Use and Minor Species