Rulemaking History for OTC Anticholinergic Drug Products

Final Monograph (21 CFR 310.533):
Drug Products Containing Active Ingredients Offered Over-the-Counter Human Use as an Anticholinergic in Cough-Cold Drug Products


Anticholinergic Drug Products

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/9/197641FR38312
Reopening of  Administative Record [PDF]3/21/198045FR18400
Reopening of Administrative Record: Camphor-containing products [PDF]9/26/198045FR63874
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]7/9/198247FR30002
    Extension of Comment Period: Guaifenesin effectiveness [PDF]8/27/198247FR37934
 Final RuleDateFR Citation
Final Monograph [PDF]11/8/198550FR46582
    Correction [PDF]12/2/198550FR49371


Page Last Updated: 04/10/2017
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