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FEDERAL REGISTER · PROPOSED RULEMarch 12, 2024PROPOSED — NOT IN FORCE

Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSPROPOSED — NOT IN FORCE
PROPOSED EFFECTIVE—
COMMENTS CLOSEJun 10, 2024 · closed
APPLIES TO · SPEQ TAGDrugVeterinary
Document type
Proposed Rule
Agency
Health and Human Services Department
Published
March 12, 2024
Comments close
June 10, 2024
Document number
2024-04840
CFR references
21 CFR 201, 21 CFR 500, 21 CFR 501, 21 CFR 510, 21 CFR 514, 21 CFR 516
Docket
FDA-2023-N-5160
RIN
0910-AI43
ABSTRACT

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.

Abstract as published in the Federal Register.

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