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

---
identifier: "/us/cfr/t21/s316.23"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 316.23 - Timing of requests for orphan-drug designation; designation of already approved drugs."
title_number: 21
title_name: "Food and Drugs"
section_number: "316.23"
section_name: "Timing of requests for orphan-drug designation; designation of already approved drugs."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "316"
part_name: "ORPHAN DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371."
regulatory_source: "57 FR 62085, Dec. 29, 1992, unless otherwise noted."
cfr_part: "316"
---


# 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.

[78 FR 35133, June 12, 2013]