21 USC § 360dd - Open protocols for investigations of drugs for rare diseases or conditions

---
identifier: "/us/usc/t21/s360dd"
source: "usc"
legal_status: "official_prima_facie"
title: "21 USC § 360dd - Open protocols for investigations of drugs for rare diseases or conditions"
title_number: 21
title_name: "FOOD AND DRUGS"
section_number: "360dd"
section_name: "Open protocols for investigations of drugs for rare diseases or conditions"
chapter_number: 9
chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
subchapter_number: "V"
subchapter_name: "DRUGS AND DEVICES"
part_number: "B"
part_name: "Drugs for Rare Diseases or Conditions"
positive_law: false
currency: "119-84"
last_updated: "2026-04-17"
format_version: "1.1.0"
generator: "[email protected]"
source_credit: "(June 25, 1938, ch. 675, § 528, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2051.)"
---


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

section 360bb of this titlesection 355(i) of this title

If a drug is designated under  as a drug for a rare disease or condition and if notice of a claimed exemption under  or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.

---

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