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.