part_subject: "INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
subpart_code: "A"
subpart_subject: "General Provisions"
section_number: "343.1"
section_subject: "Scope."
cfr_reference: "21 CFR 343.1"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(a)An over-the-counter analgesic-antipyretic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part in addition to each of the general conditions 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.