21 CFR § 312.40 - General requirements for use of an investigational new drug in a clinical investigation.
(1) The sponsor of the investigation submits an IND for the drug to FDA; the IND is in effect under paragraph (b) of this section; and the sponsor complies with all applicable requirements in this part and parts 50 and 56 with respect to the conduct of the clinical investigations; and
(b) An IND goes into effect:
(2) On earlier FDA authorization to ship the drug.
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