---
kind: "section"
citation: "21 C.F.R. § 316.28"
title: "21"
number: "316.28"
heading: "Publication of orphan-drug designations."
url: "https://uscodex.org/cfr/21/316.28"
---

# §316.28. Publication of orphan-drug designations.


Each month FDA will update a publicly available cumulative posting of all drugs designated as orphan drugs. These postings will contain the following information:

- (a) The name and address of the sponsor;
- (b) The generic name and trade name, if any, or, if neither is available, the chemical name or a meaningful descriptive name of the drug;
- (c) The date of the granting of orphan-drug designation;
- (d) The designated use in the rare disease or condition; and
- (e) If the drug loses designation after August 12, 2013, the date of it no longer having designation.

## Notes

### Amendments

[78 FR 35134, 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 35134, June 12, 2013]