[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: 21CFR640.6]

[Page 94]
 
                        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 A_Whole Blood
 
Sec. 640.6  Modifications of Whole Blood.

    Upon approval by the Director, Center for Biologics Evaluation and 
Research, of a supplement to the biologics license application for Whole 
Blood a manufacturer may prepare Whole Blood from which the 
antihemophilic factor has been removed, provided the Whole Blood meets 
the applicable requirements of this subchapter and the following 
conditions are met:
    (a) The antihemophilic factor shall be removed in accordance with 
paragraphs (a), (b), and (c) of Sec. 640.52.
    (b) Although the closed system between the red blood cells and 
plasma shall be maintained, the red blood cells shall be maintained 
between 1 and 6[deg] C at all times, including that time when the plasma 
is being frozen for removal of the antihemophilic factor.

[38 FR 32089, Nov. 20, 1973, as amended at 49 FR 23834, June 8, 1984; 50 
FR 4138, 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]

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