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 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC Antidiarrheal Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Antidiarrheal Drug Products
  
  	
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    Print**Final Monograph** (21 CFR part 335):*Antidiarrheal Drug Products for Over-the-Counter Human Use*

OTC Antidiarrheal Drug Products found on this page:

Original Active Ingredients and Labeling
	Bismuth Subsalicylate
	Time and Extent ApplicationAntidiarrheal Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking [PDF]
			3/21/1975
			40FR12902Proposed Rule
			Date
			*FR* CitationTentative Final Monograph [PDF]
			4/30/1986
			51FR16138Correction [PDF]
			7/21/1986
			51FR26170Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]
			5/16/1990
			55FR20434Correction [PDF]
			6/7/1990
			55FR23235Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]
			11/7/1990
			55FR46914Correction [PDF]
			12/3/1990
			55FR49973Technical Amendment: Correct an ingredient name [PDF]
			1/30/1992
			57FR3526Final Monograph[PDF]
			4/17/2003
			68FR18869Correction[PDF]
			6/26/2003
			68FR37963

Antidiarrheal Drug Products: Bismuth Subsalicylate

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking [PDF]
			3/21/1975
			40FR12902Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds Travelers' diarrhea indication [PDF]
			4/17/2003
			68FR18915Final Rule
			Date
			*FR* CitationFinal Rule: Adds Travelers' diarrhea indication [PDF]
			5/12/2004
			69FR26301

Antidiarrheal Drug Products: Time and Extent Application

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: *Saccharomyces boulardii*[PDF]
			8/23/2004
			69FR51852Notice of Withdrawal: *Saccharomyces boulardii*
			10/27/2009
			74FR55245

                                                                                  Content current as of:
      04/13/2017Historical Status of OTC Rulemakings
 
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