21 CFR § 316.40 - Treatment use of a designated orphan drug.

---
identifier: "/us/cfr/t21/s316.40"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 316.40 - Treatment use of a designated orphan drug."
title_number: 21
title_name: "Food and Drugs"
section_number: "316.40"
section_name: "Treatment use of a designated orphan drug."
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"
---