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In this section: Historical 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

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