CFR section
21 CFR 211.86: Use of approved components, 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 211.86 |
|---|---|
| Section | Use of approved components, 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 | Biologics, Drugs |
| Regulation text (excerpt) | Components, drug product containers, and closures approved for use shall be rotated so that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate. |
At a glance
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- 1–9 Warning letters citing this section
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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.