21 CFR 312.1
§ 312.1 Scope.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 312.1, § 312.1 Scope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86258
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Full text
(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.
(b) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.