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GUIDANCE DOCUMENT

CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter September 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2019-D-3614


Docket Number:
FDA-2019-D-3614
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance is intended for sponsors of approved applications and abbreviated applications for new animal drugs containing medically important antimicrobials for use in non-food (companion), food-producing animals, or both, that are currently approved with over-the-counter marketing status. The guidance contains information for sponsors of such new animal drugs to facilitate voluntary changes to the approved conditions of use of these drugs to prescription marketing status.

On September 14, 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. One action item included in this plan is to ensure that any medically important antimicrobial new animal drugs that continue to remain available as OTC products are brought under the oversight of licensed veterinarians.  The purpose of this guidance is to provide sponsors with specific recommendations on how to facilitate voluntary changes to the approved conditions of use of these drugs to prescription marketing status. The voluntary process outlined in this guidance will help to ensure new animal drugs containing antimicrobials of human importance are administered only under veterinary oversight and only for therapeutic uses.
 

Questions?

Contact Point
Cindy Burnsteel
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-130
Rockville, MD 20855