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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 338.3: Definition.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER D—DRUGS FOR HUMAN USE
  4. PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
  5. Subpart A—General Provisions

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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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