CFR section
21 CFR 606.110(a): 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(a) |
|---|---|
| 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, Drugs |
| Regulation text (excerpt) | (a) The use of plateletpheresis and leukapheresis procedures to obtain a product for a specific recipient may be at variance with the additional standards for specific products prescribed in this part provided that: (1) A physician has determined that the recipient must be transfused with the leukocytes or platelets from a specific donor, and (2) the procedure is performed under the supervision of a responsible physician who is aware of the health status of the donor, and the physician has… |
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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.