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HHS - 21 CFR PART 343

INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

active, Most Current
Organization: HHS
Publication Date: 1 April 2017
Status: active
Page Count: 8
scope:

(a) An over-the-counter analgesicantipyretic 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.

Document History

April 1, 2023
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter analgesicantipyretic 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...
April 1, 2021
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter analgesicantipyretic 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...
April 1, 2020
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter analgesicantipyretic 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...
April 1, 2019
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THECOUNTER HUMAN USE
(a) An over-the-counter analgesicantipyretic 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...
April 1, 2018
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter analgesicantipyretic 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...
21 CFR PART 343
April 1, 2017
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter analgesicantipyretic 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...
April 1, 2016
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter analgesicantipyretic 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...
April 1, 2015
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter analgesicantipyretic 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...
April 1, 2014
INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter analgesicantipyretic 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...
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