CFR section
21 CFR 640.65(b)(1)(iii): Plasmapheresis
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart G-Source Plasma
Key facts
| Citation | 21 CFR 640.65(b)(1)(iii) |
|---|---|
| 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, Drugs |
| Regulation text (excerpt) | (iii) A repeat donor from whom the plasmapheresis center is unable to obtain a sample for testing as prescribed in paragraph (b)(1)(i) of this section for a total period exceeding 6 months shall be processed as a new donor. |
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