21 C.F.R. § 640.22 Collection of source material.
Title 21 - Food and Drugs
(a) Whole blood used as the source of Platelets shall be collected as prescribed in §640.4. (b) If plasmapheresis is used, the procedure for collection shall be prescribed in §§640.62, 640.64 (except paragraph (c)(3)), and 640.65. (c) If plateletpheresis is used, the procedure for collection shall be as described in a biologics license application or a supplement to a biologics license application, and must have the written approval of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. (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]
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart C—Platelets
§ 640.22 Collection of source material.
