21 CFR § 333.201 - Scope.

---
identifier: "/us/cfr/t21/s333.201"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 333.201 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "333.201"
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: "333"
part_name: "TOPICAL ANTIMICROBIAL 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: "52 FR 47322, Dec. 11, 1987, unless otherwise noted."
cfr_part: "333"
---


# 333.201 Scope.

(a) An over-the-counter antifungal drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in § 330.1 of this chapter.

(b) Reference in this subpart to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.