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 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 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