---
kind: "section"
citation: "21 C.F.R. § 316.40"
title: "21"
number: "316.40"
heading: "Treatment use of a designated orphan drug."
url: "https://uscodex.org/cfr/21/316.40"
---

# §316.40. Treatment use of a designated orphan drug.


Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter.


## Notes

### Amendments

[74 FR 40945, Aug. 13, 2009]

### Authority

Authority: 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.

### Source

Source: 57 FR 62085, Dec. 29, 1992, unless otherwise noted.

### Amendments

[74 FR 40945, Aug. 13, 2009]