U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CVM GFI #5 Drug Stability Guidelines
  1. Search for FDA Guidance Documents


CVM GFI #5 Drug Stability Guidelines December 2008

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

Section 512(b) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b) establishes the requirements for new animal drug approval.  21 CFR 514.1 specifies the proper form and the information required to be submitted. Included is a requirement under section 514.1(b)(5)(x) that an applicant submit data from stability studies completed as well as information about studies that are underway to substantiate the request for a specific expiration date and provide information on the stability of the drug products.

CGMP regulations under 21 CFR Part 200 also require stability testing for pharmaceutical dosage forms (21 CFR 211) and Type A Medicated Articles (medicated premixes) (21 CFR 226).  This guideline can be used as an aid to conduct the required stability testing.

Submit Comments

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-2020-D-1385.


Contact Point
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
(240) 402-7002
Back to Top