CFR section
21 CFR 610.53(b): Dating periods for Whole Blood and blood components
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart F-Dating Period Limitations
Key facts
| Citation | 21 CFR 610.53(b) |
|---|---|
| Section | Dating periods for Whole Blood and blood components |
| Part | PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS |
| Subpart | Subpart F-Dating Period Limitations |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (b) Table of dating periods. In using the table in this paragraph, when a product in column A is stored at the storage temperature prescribed in column B, storage of a product must not exceed the dating period specified in column C, unless a different dating period is specified in the instructions for use by the blood collection, processing and storage system approved or cleared for such use by FDA. Container labels for each product must include the recommended storage temperatures. |
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