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  4. CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals
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GUIDANCE DOCUMENT

CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals September 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-2925
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

In September 2018, FDA unveiled a 5-year action plan for supporting antimicrobial stewardship in veterinary settings.  This plan builds upon the important steps the Center for Veterinary Medicine (CVM) has already taken to support the judicious use of antimicrobials in animals, and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control, or prevention of specific diseases.  This plan includes an action item intended “to ensure that all medically important antimicrobial drugs used in the feed or drinking water of food-producing animals have an appropriately targeted duration of use.”

This guidance provides information to sponsors of certain antimicrobial animal drug products who are interested in voluntarily establishing appropriately defined durations of therapeutic administration to food-producing animals where none currently exist.  The guidance also proposes timelines for stakeholders wishing to comply voluntarily with this guidance.
 

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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
John M. Mussman, DVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-130
Rockville, MD 20855
John.Mussman@fda.hhs.gov
240-402-0589
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