21 CFR § 660.1 - Antibody to Hepatitis B Surface Antigen.

---
identifier: "/us/cfr/t21/s660.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 660.1 - Antibody to Hepatitis B Surface Antigen."
title_number: 21
title_name: "Food and Drugs"
section_number: "660.1"
section_name: "Antibody to Hepatitis B Surface Antigen."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "660"
part_name: "ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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."
cfr_part: "660"
---


# 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 of this chapter, or from human donor whose blood is positive for hepatitis B surface antigen.

[40 FR 29711, July 15, 1975]