---
kind: "section"
citation: "21 U.S.C. § 360dd"
title: "21"
title_heading: "Food and Drugs"
number: "360dd"
heading: "Open protocols for investigations of drugs for rare diseases or conditions"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360dd"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part B — Drugs for Rare Diseases or Conditions"
---

# §360dd. Open protocols for investigations of drugs for rare diseases or conditions


If a [drug](/usc/21/321.md?p=g-1) is designated under [section 360bb of this title](/usc/21/360bb.md) as a [drug](/usc/21/321.md?p=g-1) for a rare disease or condition and if notice of a claimed exemption under [section 355(i) of this title](/usc/21/355.md?p=i) or regulations issued thereunder is filed for such [drug](/usc/21/321.md?p=g-1), the [Secretary](/usc/21/321.md?p=d) shall encourage the [sponsor](/usc/21/360fff.md?p=8) of such [drug](/usc/21/321.md?p=g-1) to design protocols for clinical investigations of the [drug](/usc/21/321.md?p=g-1) which may be conducted under the exemption to permit the addition to the investigations of [persons](/usc/21/321.md?p=e) with the disease or condition who need the [drug](/usc/21/321.md?p=g-1) to treat the disease or condition and who cannot be satisfactorily treated by available alternative [drugs](/usc/21/321.md?p=g-1).


## Source credit

(June 25, 1938, ch. 675, § 528, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2051.)