Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals February 2026

GUIDANCE DOCUMENT

• Docket Number: FDA-2023-D-2925
• Issued by: 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

Questions?