U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process (Drugs)
  4. Development Resources
  5. Over-the-Counter (OTC) Drugs
  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Daytime Sedative Drug Products
  1. Over-the-Counter (OTC) Drugs

Rulemaking History for OTC Daytime Sedative Drug Products

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
   Correction1/8/197641FR1498
   Correction1/26/197641FR3745
   Correction1/30/197641FR4600
Proposed RuleDateFR Citation
Tentative Final Monograph6/13/197843FR25544
Final RuleDateFR Citation
Final Monograph6/22/197944FR36378
   Correction7/15/198045FR47422