FDA Guidance on Antimicrobial Drug Durations for Food Animals

Detected February 27th, 2026

Summary

The FDA's Center for Veterinary Medicine has issued guidance for sponsors of new animal drug applications concerning medically important antimicrobial drugs used in food-producing animals. The guidance aims to facilitate voluntary changes to define durations of use for these drugs to mitigate antimicrobial resistance.

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What changed

The FDA has issued new guidance intended for sponsors of approved new animal drug applications (NADAs and ANADAs) that contain medically important antimicrobial drugs for use in food-producing animals, where the current approval has an undefined duration of use. This guidance provides recommendations for sponsors to voluntarily change the approved conditions of use to establish defined durations, aligning with principles of judicious use and efforts to mitigate the development of antimicrobial resistance. The guidance is accompanied by Docket Number FDA-2023-D-2925.

This guidance is non-binding but encourages voluntary action by drug sponsors. While comments can be submitted at any time, regulated entities should review the guidance to understand the FDA's recommendations for defining drug use durations. The primary implication is for drug manufacturers to consider updating their product approvals to include defined durations of use for relevant antimicrobial drugs to align with public health goals concerning antimicrobial resistance.

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Docket Number: FDA-2023-D-2925 Issued by: Guidance Issuing Office Center for Veterinary Medicine This guidance is intended for sponsors of approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) containing antimicrobial drugs: (1) important to human medicine (medically important antimicrobial drugs), (2) for use in or on the medicated feed of food-producing animals, and (3) that are currently approved with one or more indications that have an undefined duration of use. Medically important antimicrobial drugs and undefined duration of use are discussed further in section III. Scope of this guidance. The framework outlined in this guidance is intended to facilitate voluntary changes to have all medically important antimicrobial new animal drugs administered in alignment with the principles of judicious use.1 Establishing appropriately defined durations of use to mitigate the development of antimicrobial resistance is consistent with previous and ongoing efforts by FDA to protect public health by promoting the judicious use of medically important antimicrobial drugs in animals. This guidance provides specific recommendations on how sponsors may facilitate changes to the approved conditions of use of affected products in support of ongoing efforts to mitigate the development of antimicrobial resistance.

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-2925

Submit Comments

Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-2925.

Questions?

Contact Point CVM Center for Veterinary Medicine
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
AskCVM@fda.hhs.gov (240) 402-7002