21 C.F.R. Subpart A—General Provisions
Title 21 - Food and Drugs
(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. 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]
Title 21: Food and Drugs
PART 348—EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart A—General Provisions
§ 348.1 Scope.
§ 348.3 Definitions.
