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


Date Federal Register Citation Description
3/21/1975 40FR12902 PDF document

Advance Notice of Proposed Rule

4/30/1986 51FR16138 PDF document Tentative Final Monograph
7/21/1986 51FR26170 PDF document Correction: Tentative Final Monograph
5/16/1990 55FR20434 PDF document Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
6/7/1990 55FR23235 PDF document Correction: 5/16/1990 Proposed Rule
11/7/1990 55FR46914 PDF document Final Rule: Classifies category II and III ingredients without data as nonmonograph
12/3/1990 55FR49973 PDF document Correction: 11/7/1990 Final Rule
1/30/1992 57FR3526 PDF document Technical Amendment: Corrects an ingredient name (11/7/1990 Final Rule)
4/17/2003 68FR18869 PDF document
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Final Monograph
4/17/2003 68FR18915 PDF document
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Proposed Rule: Adds Travelers' diarrhea indication for bismuth subsalicylate
6/26/2003 68FR37963 PDF document
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Correction: Final Monograph
5/12/2004 69FR26301 PDF document
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Final Rule: Adds Travelers' diarrhea indication for bismuth subsalicylate
8/23/2004 69FR51852 PDF document
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Request for Data: Saccharomyces boulardii (Time and Extent Application)

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Date updated: May 8, 2007

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