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21 CFR 56.124

§ 56.124 Actions alternative or additional to disqualification.

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

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21 CFR 56.124, § 56.124 Actions alternative or additional to disqualification, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83496
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Disqualification of an IRB or of an institution is independent of, and neither in lieu of nor a precondition to, other proceedings or actions authorized by the act. The Food and Drug Administration may, at any time, through the Department of Justice institute any appropriate judicial proceedings (civil or criminal) and any other appropriate regulatory action, in addition to or in lieu of, and before, at the time of, or after, disqualification. The agency may also refer pertinent matters to another Federal, State, or local government agency for any action that that agency determines to be appropriate.

Legislative history

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