eCFR Reference Browser

---

title: "21 CFR §316.40"

source: "https://www.ecfr.gov/current/title-21/section-316.40"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "316"

part_subject: "ORPHAN DRUGS"

subpart_code: "E"

subpart_subject: "Open Protocols for Investigations"

section_number: "316.40"

section_subject: "Treatment use of a designated orphan drug."

cfr_reference: "21 CFR 316.40"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter.

§316.40 - Treatment use of a designated orphan drug.