21 CFR 316.23
§ 316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 316.23, § 316.23 Timing of requests for orphan-drug designation; designation of already approved drugs, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86426
- Permanent ID
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.