[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: 21CFR640.53]

[Page 93]
 
                        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 F--Cryoprecipitate
 
Sec. 640.53  Testing the blood.

    (a) Blood from which plasma is separated for the preparation of 
Cryoprecipitated AHF shall be tested as prescribed in Secs. 610.40 and 
610.45 of this chapter and Sec. 640.5 (a), (b), and (c).
    (b) The tests shall be performed on a sample of blood collected at 
the time of collecting the source blood, and such sample container shall 
be labeled with the donor's number before the container is filled.
    (c) Manufacturers of Cryoprecipitated AHF obtained from plasma 
collected by plasmapheresis shall have testing and record-keeping 
responsibilities equivalent to those prescribed in Secs. 640.71 and 
640.72.

[42 FR 21774, Apr. 29, 1977, as amended at 42 FR 37546, July 22, 1977; 
42 FR 43063, Aug. 26, 1977; 50 FR 4139, Jan. 29, 1985; 53 FR 117, Jan. 
5, 1988]