CFR section
21 CFR 211.165(f): Testing and release for distribution
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart I-Laboratory Controls
Key facts
| Citation | 21 CFR 211.165(f) |
|---|---|
| Section | Testing and release for distribution |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart I-Laboratory Controls |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (f) Drug products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed. Prior to acceptance and use, reprocessed material must meet appropriate standards, specifications, and any other relevant criteria. |
At a glance
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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.