[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.22]

[Page 89]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                          Subpart C--Platelets
 
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) If plasmapheresis is used, the procedure for collection shall be 
prescribed in Secs. 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]