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21 CFR 660.40

§ 660.40 Hepatitis B Surface Antigen.

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

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21 CFR 660.40, § 660.40 Hepatitis B Surface Antigen, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88560
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(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.

Legislative history

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