21 CFR 316.28
§ 316.28 Publication of orphan-drug designations.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 316.28, § 316.28 Publication of orphan-drug designations, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86431
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.