Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE
/ PART 348 - EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
/ Subpart A - General Provisions
Subpart A - General Provisions
§ 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]