21 CFR 640.22 - Collection of source material.
(a) Whole blood used as the source of Platelets shall be collected as prescribed in § 640.4.
(c) If plateletpheresis is used, the procedure for collection must be as prescribed in §§ 640.62, 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.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.