[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: 21CFR640.32]

[Page 103]
 
                        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 D_Plasma
 
Sec. 640.32  Collection of source material.

    (a) Whole Blood must be collected, transported, and stored as 
prescribed in Sec. 640.4. When whole blood is intended for Plasma, 
Fresh Frozen Plasma, and Liquid Plasma, until the plasma is removed, the 
whole blood must be maintained at a temperature between 1 and 6 [deg]C 
or as specified in the directions for use for the blood collecting, 
processing, and storage system approved for such use by the Director, 
Center for Biologics Evaluations and Research. Whole blood intended for 
Platelet Rich Plasma must be maintained as prescribed in Sec. 640.24 
until the plasma is removed. The red blood cells must be placed in 
storage at a temperature between 1 and 6 [deg]C immediately after the 
plasma is separated.
    (b) Plasma obtained by plasmapheresis shall be collected as 
prescribed in Sec. Sec. 640.62, 640.64 (except that paragraph (c)(3) of 
Sec. 640.64 shall not apply), and Sec. 640.65.

[42 FR 59878, Nov. 22, 1977, as amended at 45 FR 27927, Apr. 25, 1980; 
50 FR 4139, Jan. 29, 1985; 64 FR 45372, Aug. 19, 1999; 72 FR 45888, Aug. 
16, 2007]