CFR section
21 CFR 211.170(a)(3): Reserve samples
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart I-Laboratory Controls
Key facts
| Citation | 21 CFR 211.170(a)(3) |
|---|---|
| Section | Reserve samples |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart I-Laboratory Controls |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (3) For an active ingredient in an OTC drug product that is exempt from bearing an expiration date under § 211.137, the reserve sample shall be retained for 3 years after distribution of the last lot of the drug product containing the active ingredient. |
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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.