21 CFR 338.1 - Scope.
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(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.
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.