21 CFR 660.40 - Hepatitis B Surface Antigen.

Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

View all text of Subpart E [§ 660.40 - § 660.46]

§ 660.40 - Hepatitis B Surface Antigen.

(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.

authority: 21 U.S.C. 321,331,351,352,353,355,360,360c,360d,360h,360i,371,372; 42 U.S.C. 216,262,263,263a,264

cite as: 21 CFR 660.40