[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: 21CFR640.21]

[Page 100-101]
 
                        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. 640.21  Suitability of donors.

    (a) Whole blood donors shall meet the criteria for suitability 
prescribed in Sec. 640.3.
    (b) [Reserved]
    (c) Plateletpheresis donors must meet the criteria for suitability 
as prescribed in Sec. Sec. 640.3 and 640.63(c)(6) or as described in an 
approved biologics license application (BLA) or an approved

[[Page 101]]

supplement to a BLA. Informed consent must be obtained as prescribed in 
Sec. 640.61.

[40 FR 4304, Jan. 29, 1975, as amended at 49 FR 23834, June 8, 1984; 64 
FR 56453, Oct. 20, 1999; 72 FR 45887, Aug. 16, 2007]