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CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles June 2024


Not for implementation.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This guidance is being distributed for comment purposes only.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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2024-D-1202

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) information for Type A medicated articles.  Type A medicated articles contain new animal drugs and provide for administration of these drugs in animal feed.  Type A medicated articles are intended solely for use in the manufacture of another Type A medicated article or in the manufacture of a Type B or Type C medicated feed.   Because Type A medicated articles are not directly administered to the animal, there are some issues specific to Type A medicated articles that do not apply to other new animal drug dosage forms.  These unique considerations are highlighted in this guidance under the relevant Common Technical Document - Quality (CTD-Q)  section headings.


Contact Point
Heather Longstaff
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-147
Rockville, MD 20855
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