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U.S. Department of Health and Human Services


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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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 9/9/1976 41FR38312
Reopening of  Administative Record [PDF] 3/21/1980 45FR18400
Reopening of Administrative Record: Camphor-containing products [PDF] 9/26/1980 45FR63874
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 7/9/1982 47FR30002
    Extension of Comment Period: Guaifenesin effectiveness [PDF] 8/27/1982 47FR37934
 Final Rule Date FR Citation
Final Monograph [PDF] 11/8/1985 50FR46582
    Correction [PDF] 12/2/1985 50FR49371