CFR section
21 CFR 211.166(a)(5): Stability testing
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart I-Laboratory Controls
Key facts
| Citation | 21 CFR 211.166(a)(5) |
|---|---|
| Section | Stability testing |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart I-Laboratory Controls |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Devices, Drugs |
| Regulation text (excerpt) | (5) Testing of drug products for reconstitution at the time of dispensing (as directed in the labeling) as well as after they are reconstituted. |
At a glance
- 1–9 Inspections citing this section
- 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.