21 CFR § 348.1 - Scope.

---
identifier: "/us/cfr/t21/s348.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 348.1 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "348.1"
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: "348"
part_name: "EXTERNAL ANALGESIC 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: "57 FR 27656, June 19, 1992, unless otherwise noted."
cfr_part: "348"
---


# 348.1 Scope.

(a) An over-the-counter external analgesic drug product in a form suitable for topical 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 21 unless otherwise noted.