[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.21]

[Page 96]
 
                        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 Contents
 
                           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) Plasmapheresis donors shall meet the criteria for suitability 
prescribed in Sec. 640.63, excluding the phrase ``other than malaria'' 
in paragraph (c)(9). Informed consent shall be required as prescribed in 
Sec. 640.61.
    (c) Plateletpheresis donors shall meet criteria for suitability as 
described in a biologics license application or a supplement to the 
biologics license application, and must have the written approval of the 
Director, Center for Biologics Evaluation and Research, Food and Drug 
Administration.

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