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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Antidiarrheal Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Antidiarrheal Drug Products

Final Monograph (21 CFR part 335):
Antidiarrheal Drug Products for Over-the-Counter Human Use 

OTC Antidiarrheal Drug Products found on this page:

Antidiarrheal Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 3/21/1975 40FR12902
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 4/30/1986 51FR16138
    Correction [PDF] 7/21/1986 51FR26170
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Correct an ingredient name [PDF] 1/30/1992 57FR3526
Final Monograph[PDF] 4/17/2003 68FR18869
Correction[PDF] 6/26/2003 68FR37963

Antidiarrheal Drug Products: Bismuth Subsalicylate

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 3/21/1975 40FR12902
Proposed Rule Date FR Citation
Proposed Rule: Adds Travelers' diarrhea indication [PDF] 4/17/2003 68FR18915
Final Rule Date FR Citation
Final Rule: Adds Travelers' diarrhea indication [PDF] 5/12/2004 69FR26301

Antidiarrheal Drug Products: Time and Extent Application

Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Saccharomyces boulardii [PDF] 8/23/2004 69FR51852
Notice of Withdrawal: Saccharomyces boulardii 10/27/2009 74FR55245

 

 
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