Standard: HHS - 21 CFR PART 338
NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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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.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
|Organization:||Food and Drug Administration (Medical Products Quality Assurance)|
|Document Number:||21 cfr part 338|
|Change Type:||COMPLETE REVISION|
|Most Recent Revision:||YES|
|Document #||Change Type||Update Date||Revision||Status|
|21 CFR PART 338||Change Type: COMPLETE REVISION||Update Date: 2017-04-01||Status: ACTV|
|21 CFR PART 338||Change Type: COMPLETE REVISION||Update Date: 2015-04-01||Status: ACTV|
|21 CFR PART 338||Change Type: COMPLETE REVISION||Update Date: 2016-04-01||Status: ACTV|