[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: 21CFR640.80]

[Page 109]
 
                        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 H_Albumin (Human)
 
Sec. 640.80  Albumin (Human).


    (a) Proper name and definition. The proper name of the product shall 
be Albumin (Human). The product is defined as a sterile solution of the 
albumin derived from human plasma.
    (b) Source material. The source material of Albumin (Human) shall be 
plasma recovered from Whole Blood prepared as prescribed in Sec. Sec. 
640.1 through 640.5, or Source Plasma prepared as prescribed in 
Sec. Sec. 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 27582, May 31, 1977, as amended at 50 FR 4140, Jan. 29, 1985; 64 
FR 26286, May 14, 1999]