21 CFR § 346.1 - Scope.

---
identifier: "/us/cfr/t21/s346.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 346.1 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "346.1"
section_name: "Scope."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "346"
part_name: "ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "55 FR 31779, Aug. 3, 1990, unless otherwise noted."
cfr_part: "346"
---


# 346.1 Scope.

(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.