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U.S. Department of Health and Human Services

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Rulemaking History for OTC Antidiarrheal Drug Proucts

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