StacksVerified U.S. regulatory reference

21 CFR §660.40

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 Hepatitis B Surface Antigen (HBsAg), which shall consist of a serum or tissue preparation containing one or more subtypes of the Hepatitis B Surface Antigen.
  2. (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 § 600.11 of this chapter, or from human donors whose blood is positive for the Hepatitis B Surface Antigen.