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(a) Whole blood used as the source of Platelets shall be collected as prescribed in § 640.4.
(b) [Reserved by 72 FR 45887]
(c) If plateletpheresis is used, the procedure for collection must be as prescribed in §§ 640.21, 640.64 (except paragraph (c)), and 640.65, or as described in an approved biologics license application (BLA) or an approved supplement to a BLA.
(d) The phlebotomy shall be performed by a single uninterrupted venipuncture with minimal damage to, and minimal manipulation of, the donor's tissue.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.640.22 Collection of source material - last updated October 03, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-640-22.html
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