---
kind: "section"
citation: "21 C.F.R. § 660.40"
title: "21"
number: "660.40"
heading: "Hepatitis B Surface Antigen."
url: "https://uscodex.org/cfr/21/660.40"
---

# §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](/cfr/21/600.11.md) of this chapter, or from human donors whose blood is positive for the Hepatitis B Surface Antigen.

## Notes

### Source

Source: 44 FR 36382, June 22, 1979, unless otherwise noted.

### Authority

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.