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

GUIDANCE DOCUMENT

CVM GFI #5 Drug Stability Guidelines December 2008

Final
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

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002