21 CFR 640.22 - Collection of source material.

Regulations last checked for updates: Nov 23, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

View all text of Subpart C [§ 640.20 - § 640.25]

§ 640.22 - Collection of source material.

(a) Whole blood used as the source of Platelets shall be collected as prescribed in § 640.4.

(b) [Reserved]

(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]

authority: 21 U.S.C. 321,351,352,353,355,360,371; 42 U.S.C. 216,262,263,263a,264

source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

cite as: 21 CFR 640.22