[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: 21CFR660.1]

[Page 119]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 660_ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--
 
            Subpart A_Antibody to Hepatitis B Surface Antigen
 
Sec. 660.1  Antibody to Hepatitis B Surface Antigen.


    (a) Proper name and definition. The proper name of this product 
shall be Antibody to Hepatitis B Surface Antigen. The product is defined 
as a preparation of serum containing antibody to hepatitis B surface 
antigen.
    (b) Source. The source of this product shall be plasma or blood, 
obtained aseptically from animals immunized with hepatitis B surface 
antigen, which have met the applicable requirements of Sec. 600.11 of 
this chapter, or from human donor whose blood is positive for hepatitis 
B surface antigen.

[40 FR 29711, July 15, 1975]