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21CFR348.1

§ 348.1 Scope.

Regulation Text

(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.

Authority

21 U.S.C. 321,351,352,353,355,360,371.

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21CFR348.1 — § 348.1 Scope. | CFR Explorer | BioRegHub