CFR section
21 CFR 606.110(b): Plateletpheresis, leukapheresis, and plasmapheresis
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart F-Production and Process Controls
Key facts
| Citation | 21 CFR 606.110(b) |
|---|---|
| Section | Plateletpheresis, leukapheresis, and plasmapheresis |
| Part | PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
| Subpart | Subpart F-Production and Process Controls |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (b) Plasmapheresis of donors who do not meet the donor requirements of §§ 630.10, 630.15, 640.64 and 640.65 of this chapter for the collection of plasma containing rare antibodies shall be permitted only with the prior approval of the Director, Center for Biologics Evaluation and Research. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.