Current through September 30, 2024
Section 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 §§ 640.21 , 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.40 FR 4304, Jan. 29, 1975, as amended at 45 FR 27927, Apr. 25, 1980; 49 FR 23834, June 8, 1984; 50 FR 4139, Jan. 29, 1985; 55 FR 11013, Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 64 FR 45372, Aug. 19, 1999; 64 FR 56453, Oct. 20, 1999; 72 FR 45887, Aug. 16, 2007; 80 FR 29904, May 22, 2015