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U.S. Department of Health and Human Services


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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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 12/8/1975 40FR57292
    Correction [PDF] 1/8/1976 41FR1498
    Correction [PDF] 1/26/1976 41FR3745
    Correction [PDF] 1/30/1976 41FR4600
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 6/13/1978 43FR25544
Final Rule Date FR Citation
Final Monograph [PDF] 6/22/1979 44FR36378
    Correction [PDF] 7/15/1980 45FR47422