---
kind: "section"
citation: "21 C.F.R. § 316.23"
title: "21"
number: "316.23"
heading: "Timing of requests for orphan-drug designation; designation of already approved drugs."
url: "https://uscodex.org/cfr/21/316.23"
---

# §316.23. Timing of requests for orphan-drug designation; designation of already approved drugs.

- (a) A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.
- (b) A sponsor may request orphan-drug designation of an already approved drug for an unapproved use without regard to whether the prior marketing approval was for a rare disease or condition.

## Notes

### Amendments

[78 FR 35133, June 12, 2013]

### Authority

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

### Source

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

### Amendments

[78 FR 35133, June 12, 2013]