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Electronic Code of Federal Regulations

e-CFR data is current as of May 28, 2020

Title 21Chapter ISubchapter DPart 343 → Subpart A


Title 21: Food and Drugs
PART 343—INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE


Subpart A—General Provisions


Contents
§343.1   Scope.
§343.3   Definitions.

§343.1   Scope.

(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.

§343.3   Definitions.

As used in this part:

Analgesicantipyretic drug. An agent used to alleviate pain and to reduce fever.

Cardiovascular drug. An agent used to prevent ischemic events.

Rheumatologic drug. An agent used for the treatment of rheumatologic disorders.

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