StacksVerified U.S. regulatory reference

21 CFR §660.1

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (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.