---
kind: "section"
citation: "21 C.F.R. § 312.40"
title: "21"
number: "312.40"
heading: "General requirements for use of an investigational new drug in a clinical investigation."
url: "https://uscodex.org/cfr/21/312.40"
---

# §312.40. General requirements for use of an investigational new drug in a clinical investigation.

- (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)](#b) of this section; and the sponsor complies with all applicable requirements in this part and parts [50](/cfr/21/part50.md) and [56](/cfr/21/part56.md) 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](/cfr/21/part50.md) and [56](/cfr/21/part56.md).
- (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](/cfr/21/312.42.md); 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)](#b) of this section.

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

### Source

Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.