21 CFR 660.4

§ 660.4 Potency test.

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

Cite this

Citation: 21 CFR 660.4, § 660.4 Potency test, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88540
Permanent ID: ys:prov:88540@1
SHA-256: 27c6f550796a29abd2e9f3bd03c6cf5d29cdeeffb7b3e616b136653cdc60dbb8

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Full text

To be satisfactory for release, each filling of Antibody to Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Surface Antigen Panel and shall be sufficiently potent to detect the antigen 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.