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21 CFR 660.1

§ 660.1 Antibody to Hepatitis B Surface Antigen.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 660.1, § 660.1 Antibody to Hepatitis B Surface Antigen, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88537
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.