21 CFR 316.40

§ 316.40 Treatment use of a designated orphan drug.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 316.40, § 316.40 Treatment use of a designated orphan drug, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86439
Permanent ID: ys:prov:86439@1
SHA-256: 5bd20faa0070d3aa0cba6f53e7e1b2b1ae94c59e909258bcdfcfe0882eac15e6

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Full text

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

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.