Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 640  /  Sec. 640.22 Collection of source material.

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

(b) [Reserved]

(c) If plateletpheresis is used, the procedure for collection must be as prescribed in Sec. Sec. 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. [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]