21 CFR 660.43

§ 660.43 Potency test.

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

Cite this

Citation: 21 CFR 660.43, § 660.43 Potency test, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88562
Permanent ID: ys:prov:88562@1
SHA-256: 7ada609783237a6e9a455d02fcd5a7f0b58c1eab78130d4a5ae2bf5e8c4a238c

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

To be satisfactory for release, each filling of Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Antiserum Panel and shall be sufficiently potent to be able to detect the antibody in the appropriate sera of the reference panel by all test methods recommended by the manufacturer in the package insert.

Legislative history

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