[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: 21CFR660.40]

[Page 116-117]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--Table of Contents
 
                 Subpart E--Hepatitis B Surface Antigen
 
Sec. 660.40  Hepatitis B Surface Antigen.

    Source: 44 FR 36382, June 22, 1979, unless otherwise noted.


    (a) Proper name and definition. The proper name of this product 
shall be Hepatitis B Surface Antigen (HBsAg), which shall consist of a 
serum or tissue preparation containing one or more

[[Page 117]]

subtypes of the Hepatitis B Surface Antigen.
    (b) Source. The source of the product shall be blood, plasma, serum, 
or tissue, obtained aseptically from nonhuman primates that have met the 
applicable requirements of Sec. 600.11 of this chapter, or from human 
donors whose blood is positive for the Hepatitis B Surface Antigen.