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e-CFR data is current as of August 12, 2020

Title 21Chapter ISubchapter DPart 338 → Subpart A


Title 21: Food and Drugs
PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE


Subpart A—General Provisions


Contents
§338.1   Scope.
§338.3   Definition.

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§338.1   Scope.

(a) An over-the-counter nighttime sleep-aid drug product in a form suitable for oral 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.

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§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.

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