{"data":{"id":"us/21-cfr-338.1","jurisdiction":"us","citation":"21 CFR 338.1","heading":"Scope.","body":"(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.\n(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE","Subpart A—General Provisions"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"6a9d2b876cb6ee9697035828560d39382b2c96183cf523e8dbd6fe163bbf3475","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-336.80","next":"us/21-cfr-338.3"},"notice":"GroundRules: Original legal text. Not legal advice."}