21 CFR 348.3 - Definitions.

Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

Collapse to view only § 348.3 - Definitions.

Table of Contents

§ 348.1 - Scope.

(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.

§ 348.3 - Definitions.

As used in this part:

(a) Male genital desensitizing drug product. A drug product applied to the penis to help in temporarily slowing the onset of ejaculation.

(b) [Reserved]

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

source: 57 FR 27656, June 19, 1992, unless otherwise noted.

cite as: 21 CFR 348.3