21 CFR 660.22
§ 660.22 Potency requirements with reference preparations.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 660.22, § 660.22 Potency requirements with reference preparations, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88547
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Full text
(a) Potency requirements. Products for which reference Blood Grouping Reagents are available shall have a potency titer value at least equal to that of the reference preparation.
(b) Reference preparations. Reference Blood Grouping Reagents shall be obtained from the Food and Drug Administration, Center for Biologics Evaluation and Research, Reagents and Standards Shipping, 10903 New Hampshire Ave., Bldg. 75, Rm. G704, Silver Spring, MD 20993-0002, and shall be used as described in the accompanying package insert for determining the potency of Blood Grouping Reagents.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.