[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.22]

[Page 101]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 640_ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of 
 
                           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) [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]