21 CFR 316.2

§ 316.2 Purpose.

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

Cite this

Citation: 21 CFR 316.2, § 316.2 Purpose, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86415
Permanent ID: ys:prov:86415@1
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Full text

The purpose of this part is to establish standards and procedures for determining eligibility for the benefits provided for in section 2 of the Orphan Drug Act, including written recommendations for investigations of orphan drugs, a 7-year period of exclusive marketing, and treatment use of investigational orphan drugs. This part is also intended to satisfy Congress' requirements that FDA promulgate procedures for the implementation of sections 525(a) and 526(a) of the act.

Legislative history

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