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  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Anticholinergic Drug Products
  1. Status of OTC Rulemakings

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