CFR section
21 CFR 640.65(b)(4): Plasmapheresis
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart G-Source Plasma
Key facts
| Citation | 21 CFR 640.65(b)(4) |
|---|---|
| Section | Plasmapheresis |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart G-Source Plasma |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (4) The amount of whole blood, not including anticoagulant, removed from a donor during a manual plasmapheresis procedure or in any 2-day period shall not exceed 1,000 milliliters unless the donor's weight is 175 pounds or greater, in which case the amount of whole blood, not including anticoagulant, removed from the donor during a manual plasmapheresis procedure or in any 2-day period shall not exceed 1,200 milliliters. |
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