[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: 21CFR640.30]

[Page 91]
 
                        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 D--Plasma
 
Sec. 640.30  Plasma.


    (a) Proper name and definition. The proper name of this product 
shall be Plasma. The product is defined as the fluid portion of one unit 
of human blood intended for intravenous use which in a closed system, 
has been collected, stabilized against clotting, and separated from the 
red blood cells.
    (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]