U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CPG Sec. 480.300 Lack of Expiration Date of Stability Data
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

CPG Sec. 480.300 Lack of Expiration Date of Stability Data March 1995

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

*The CGMP regulations (21 CFR 211.137) have required that drug products packaged since September 29, 1979, bear an expiration date which is supported by appropriate stability data, with limited exceptions. OTC drug products which have no dosage limitation and which are stable for at least three years as demonstrated by appropriate data are exempt from the requirement to bear an expiration date. Homeopathic drugs, while required to have a limited evaluation of stability, are also exempt from the requirement to bear an expiration date. Additionally, allergenic extracts that are labeled "No U.S. Standard of Potency" are exempt from the requirements to be labeled with an expiration date and the performance of stability studies.*


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.