Rulemaking History for OTC Antidiarrheal Drug Products

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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

OTC Antidiarrheal Drug Products found on this page:

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

**Antidiarrheal Drug Products: Bismuth Subsalicylate**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	3/21/1975	40FR12902
Proposed Rule	Date	FR Citation
Proposed Rule: Adds Travelers' diarrhea indication	4/17/2003	68FR18915
Final Rule	Date	FR Citation
Final Rule: Adds Travelers' diarrhea indication	5/12/2004	69FR26301

**Antidiarrheal Drug Products: Time and Extent Application**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data: Saccharomyces boulardii	8/23/2004	69FR51852

Date created: December 28, 2006; Last updated: May 4, 2007