21 C.F.R. Subpart A—General Provisions
Title 21 - Food and Drugs
(a) An over-the-counter stimulant drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in §330.1. (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: Stimulant. A drug which helps restore mental alertness or wakefulness during fatigue or drowsiness.
Title 21: Food and Drugs
PART 340—STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart A—General Provisions
§ 340.1 Scope.
§ 340.3 Definition.
