21 CFR 660.54
§ 660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 660.54, § 660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88571
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Full text
The following tests shall be performed using test procedures approved by the Director, Center for Biologics Evaluation and Research:
(a) Potency tests for determining anti-IgG and anti-complement activity.
(b) Specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.