C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 312—INVESTIGATIONAL NEW DRUG APPLICATION › Subpart C—Administrative Actions

21 C.F.R. § 312.40

General requirements for use of an investigational new drug in a clinical investigation

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(a) An investigational new drug may be used in a clinical investigation if the following conditions are met:

(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

(2) Each participating investigator conducts his or her investigation in compliance with the requirements of this part and parts 50 and 56.

(b) An IND goes into effect:

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42; or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.

(c) A sponsor may ship an investigational new drug to investigators named in the IND:

(1) Thirty days after FDA receives the IND; or

(2) On earlier FDA authorization to ship the drug.

(d) An investigator may not administer an investigational new drug to human subjects until the IND goes into effect under paragraph (b) of this section.

Notes of Decisions
Cited in 2 cases, 1998–1999 · leading case: Pub. Citizen Health Rsch. Grp. v. Food & Drug Admin., 185 F.3d 898 (D.C. Cir. 1999).
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Pub. Citizen Health Rsch. Grp. v. Food & Drug Admin., 185 F.3d 898 (D.C. Cir. 1999). “See 21 C.F.R. §§ 312.40 (b), 312.42. During clinical testing the company must update its IND with safety reports, annual reports on the progress of the testing, any amendments to the testing protocols, and other information.”
Cowan v. United States, 5 F. Supp. 2d 1235 (N.D. Okla. 1998). “21 C.F.R. § 312.40 (a)(1). Therefore, in accordance with these regulations, before a new drug can be used, the sponsor must first obtain an IND.”
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