CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART A—General Provisions (§338.1 to §338.3) > 338.3—Definition.

338.3—Definition.

As used in this part:
Nighttime sleep-aid. A drug that is useful for the relief of occasional sleeplessness by individuals who have difficulty falling asleep.