U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-1202
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.

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-2024-D-1202.

Questions?

Contact Point
Heather Longstaff
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
Heather.Longstaff@fda.hhs.gov
240-402-0651
Back to Top