21 CFR § 316.28 - Publication of orphan-drug designations.
---
identifier: "/us/cfr/t21/s316.28"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 316.28 - Publication of orphan-drug designations."
title_number: 21
title_name: "Food and Drugs"
section_number: "316.28"
section_name: "Publication of orphan-drug designations."
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"
---
# 316.28 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.
[78 FR 35134, June 12, 2013]