CFR Subpart A

CFR Subpart A
in effect

21 C.F.R. § 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.

21 C.F.R. § 343.3 Definitions.

As used in this part: Analgesic—antipyretic 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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