CFR section
21 CFR 640.21(e): Eligibility of donors
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart C-Platelets
Key facts
| Citation | 21 CFR 640.21(e) |
|---|---|
| Section | Eligibility of donors |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart C-Platelets |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (e) Frequency of plateletpheresis collection. (1) The donor may donate no more than a total of 24 plateletpheresis collections during a 12-month rolling period. (2) When you collect fewer than 6 × 1011 platelets, you must wait at least 2 calendar days before any subsequent plateletpheresis collection. You must not attempt to collect more than 2 collections within a 7 calendar day period. (3) When you collect 6 × 1011 or more platelets, you must wait at least 7 calendar days before any subsequent… |
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