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 340 - STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
/ Subpart A - General Provisions
Subpart A - General Provisions
§ 340.1 Scope.
(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.
§ 340.3 Definition.
As used in this part:
Stimulant. A drug which helps restore mental alertness or wakefulness during fatigue or drowsiness.