21 CFR 211.94: Drug product containers and closures
Requires drug containers and closures to be non-reactive, non-additive, non-absorptive, protective against external deterioration or contamination, clean, sterilized and depyrogenated (with validated depyrogenation) when needed, and controlled by written specifications and procedures.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart E, Control of Components and Drug Product Containers and Closures
How FDA words it
The opening lines investigators use most when they cite 211.94, from the 483s we hold.
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.Most used
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.211.94(c)
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.211.94(c)
Cited over time
483s citing 211.94, by yearMost citations in 2017. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2017.
Recent 483s citing 211.94
- Newton Laboratories, Inc. · Conyers, GeorgiaContainer closure systems do not provide adequate protection against foreseeable… Mar 26, 2026
- JKR Pharmacy Ventures, LLC dba Doc · Lexington, KentuckyThe final and intermediate containers/closures used for ding product intended to be… Dec 19, 2025
- JKR Pharmacy Ventures, LLC dba Lane's Veterinary Pharmacy · Lexington, KentuckyThe final and intermediate containers/closures used for drug product intended to be… Dec 3, 2025
- Pet scri pt Inc · Paris, TexasDrug product containers and closures were not clean and sterilized and processed to… Sep 18, 2025
- AnazaoHealth Corporation · —Container closure systems do not provide adequate protection against foreseeable… Sep 23, 2024
The regulation text
§ 211.94 Drug product containers and closures.
(a)Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.
(b)Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
(c)Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Such depyrogenation processes shall be validated.
(d)Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008; 81 FR 81697, Nov. 18, 2016; 89 FR 51769, June 18, 2024]
Questions
What does 21 CFR 211.94 require?
Requires drug containers and closures to be non-reactive, non-additive, non-absorptive, protective against external deterioration or contamination, clean, sterilized and depyrogenated (with validated depyrogenation) when needed, and controlled by written specifications and procedures.
How do FDA investigators word a 211.94 observation?
The most common opening is: “Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.”
Which sections are cited alongside 211.94?
In the same 483s, investigators most often also cite 211.113 (Control of microbiological contamination), 211.42 (Design and construction features), 211.192 (Production record review), 211.166 (Stability testing).