21 CFR 346.1
§ 346.1 Scope.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 346.1, § 346.1 Scope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86615
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Full text
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 212 unless otherwise noted.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.