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  7. Rulemaking History for OTC Antidiarrheal Drug Products
  1. 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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]3/21/197540FR12902
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]4/30/198651FR16138
    Correction [PDF]7/21/198651FR26170
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Correct an ingredient name [PDF]1/30/199257FR3526
Final Monograph[PDF]4/17/200368FR18869
Correction[PDF]6/26/200368FR37963

Antidiarrheal Drug Products: Bismuth Subsalicylate

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]3/21/197540FR12902
Proposed RuleDateFR Citation
Proposed Rule: Adds Travelers' diarrhea indication [PDF]4/17/200368FR18915
Final RuleDateFR Citation
Final Rule: Adds Travelers' diarrhea indication [PDF]5/12/200469FR26301

Antidiarrheal Drug Products: Time and Extent Application

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Saccharomyces boulardii [PDF]8/23/200469FR51852
Notice of Withdrawal: Saccharomyces boulardii10/27/200974FR55245