[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: 21CFR640.90]

[Page 104]
 
                        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 I--Plasma Protein Fraction (Human)
 
Sec. 640.90  Plasma Protein Fraction (Human).

    Source: 42 FR 27583, May 31, 1977, unless otherwise noted.


    (a) Proper name and definition. The proper name of the product shall 
be Plasma Protein Fraction (Human). The product is defined as a sterile 
solution of protein composed of albumin and globulin, derived from human 
plasma.
    (b) Source material. The source material of Plasma Protein Fraction 
(Human) shall be plasma recovered from Whole Blood prepared as 
prescribed in Secs. 640.1 through 640.5, or Source Plasma prepared as 
prescribed in Secs. 640.60 through 640.76.
    (c) Additives in source material. Source material shall not contain 
an additive unless it is shown that the processing method yields a final 
product free of the additive to such extent that the continued safety, 
purity, potency, and effectiveness of the final product will not be 
adversely affected.

[42 FR 27583, May 31, 1977, as amended at 64 FR 26286, May 14, 1999]