21 CFR § 358.101 - Scope.

---
identifier: "/us/cfr/t21/s358.101"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 358.101 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "358.101"
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: "358"
part_name: "MISCELLANEOUS EXTERNAL 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 33255, Aug. 14, 1990, unless otherwise noted."
cfr_part: "358"
---


# 358.101 Scope.

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

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