CFR section
21 CFR 211.94(b): Drug product containers and closures
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart E-Control of Components and Drug Product Containers and Closures
Key facts
| Citation | 21 CFR 211.94(b) |
|---|---|
| Section | Drug product containers and closures |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart E-Control of Components and Drug Product Containers and Closures |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (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. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.