---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchD/part316"
level: "part"
label: "Part 316"
heading: "Orphan Drugs"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchD-part316"
sections_count: 24
---

# Part 316 — Orphan Drugs

Title 21 C.F.R. — Food and Drugs › Chapter I — Food and Drug Administration, Department of Health and Human Services › Subchapter D — Drugs for Human Use

## Contents

- [Subpart A — General Provisions](/cfr/21/chI-subchD-part316-subpartA.md)
- [Subpart B — Written Recommendations for Investigations of Orphan Drugs](/cfr/21/chI-subchD-part316-subpartB.md)
- [Subpart C — Designation of an Orphan Drug](/cfr/21/chI-subchD-part316-subpartC.md)
- [Subpart D — Orphan-drug Exclusive Approval](/cfr/21/chI-subchD-part316-subpartD.md)
- [Subpart E — Open Protocols for Investigations](/cfr/21/chI-subchD-part316-subpartE.md)
- [Subpart F — Availability of Information](/cfr/21/chI-subchD-part316-subpartF.md)