Description
Revisions to 21 CFR Part 211, Current Good Manufacturing Practices for Finished Pharmaceuticals (CGMP) introduced requirements concerning expiration dating (21 CFR 211.137) and stability testing (21 CFR 211.166) which became effective September 29, 1979. The purpose of this guide is to delineate those situations in which the Center is prepared to consider regulatory action.
Scope & Applicability
Product Classes
2Lack of a written stability program for bulk drug substances
21 CFR Part 211 applies to finished pharmaceuticals
Regulatory Context
Attributes
3expressed as a numerical value or range
Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life
should be based on appropriate supportive stability data
Related CFR Sections (2)
- 21CFR211.166§ 211.166 Stability testing.
(a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include:Read full regulation →
- 21CFR211.137§ 211.137 Expiration dating.
(a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166 .Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
- 2025-12-02
Compounding Pharmacy/Adulterated Drug Products
PQ Pharmacy, LLC
See Also (8)
- Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (Status: Final)
- Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Status: Final)
- Shelf Life of Medical Devices (Status: Final)
- CPG Sec. 480.300 Lack of Expiration Date of Stability Data (Status: Final)
- Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for Industry (Status: Final)
- Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products (Status: Draft)
- Temporary Policies for Compounding Certain Parenteral Drug Products: Guidance for Industry (Status: Final)
- Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry (Status: Final)