---
kind: "section"
citation: "21 C.F.R. § 660.1"
title: "21"
number: "660.1"
heading: "Antibody to Hepatitis B Surface Antigen."
url: "https://uscodex.org/cfr/21/660.1"
---

# §660.1. Antibody to Hepatitis B Surface Antigen.

- (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.
- (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](/cfr/21/600.11.md) of this chapter, or from human donor whose blood is positive for hepatitis B surface antigen.

## Notes

### Amendments

[40 FR 29711, July 15, 1975]

### 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.

### Amendments

[40 FR 29711, July 15, 1975]