CFR section
21 CFR 600.12(b)(1): Records
PART 600-BIOLOGICAL PRODUCTS: GENERAL · Subpart B-Establishment Standards
Key facts
| Citation | 21 CFR 600.12(b)(1) |
|---|---|
| Section | Records |
| Part | PART 600-BIOLOGICAL PRODUCTS: GENERAL |
| Subpart | Subpart B-Establishment Standards |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (1) General. Records shall be retained for such interval beyond the expiration date as is necessary for the individual product, to permit the return of any clinical report of unfavorable reactions. The retention period shall be no less than five years after the records of manufacture have been completed or six months after the latest expiration date for the individual product, whichever represents a later date. |
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