[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: 21CFR640.30]

[Page 102]
 
                        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. 640.30  Plasma.


    (a) Proper name and definition. The proper name of this component is 
Plasma. The component is defined as:
    (1) The fluid portion of one unit of human blood intended for 
intravenous use which is collected in a closed system, stabilized 
against clotting, and separated from the red cells; or
    (2) The fluid portion of human blood intended for intravenous use 
which is prepared by apheresis methods as specified in the directions 
for use for the blood collecting, processing, and storage system 
including closed and open systems.
    (b) Source. (1) Plasma shall be obtained by separating plasma from 
blood collected from blood donors or by plasmapheresis.
    (2) Plasma may be obtained from a unit of Whole Blood collected by 
another licensed establishment.

[42 FR 59878, Nov. 22, 1977; 48 FR 13026, Mar. 29, 1983, as amended at 
50 FR 4139, Jan. 29, 1985; 72 FR 45888, Aug. 16, 2007]

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