21 C.F.R. § 660.1

Current through October 31, 2024
Section 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 § 600.11 of this chapter, or from human donor whose blood is positive for hepatitis B surface antigen.

21 C.F.R. §660.1

40 FR 29711, July 15, 1975