Rulemaking History for OTC Daytime Sedative Drug Products

Final Monograph (21 CFR 310.519):
Drug products marketed as over-the-counter (OTC) daytime sedatives

Daytime Sedative Drug Products

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking12/8/197540FR57292
Proposed RuleDateFR Citation
Tentative Final Monograph6/13/197843FR25544
Final RuleDateFR Citation
Final Monograph6/22/197944FR36378

Page Last Updated: 06/01/2017
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