21 C.F.R. § 660.40
Hepatitis B Surface Antigen.
Cite as 21 C.F.R. § 660.40 (2026)
(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.
(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.
- Cross-references to the CFR
- 600.11