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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 Exocrine Pancreatic Insufficiency Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Exocrine Pancreatic Insufficiency Drug Products
  
  	
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    Print**Final Monographs**(21 CFR 310.543)**:***Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency*

OTC Exocrine Pancreatic Insufficiency Drug Products found on this page:

Original Active Ingredients and Labeling
	Nonnonograph IngredientsExocrine Pancreatic Insufficiency Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			12/21/1979
			44FR75666Correction
			3/25/1980
			45FR19266Extension of Comment Period
			3/25/1980
			45FR19265Proposed Rule
			Date
			*FR* CitationTentative Final Monograph Pancreatin and pancrelipase are GRASE
			11/8/1985
			50FR46594Correction
			12/2/1985
			50FR49409Proposed Rule: Withdraws tentative final monograph; No GRASE active ingredients
			7/15/1991
			56FR32282Notice: Public workshop to discuss testing (needed for NDAs)
			3/11/1992
			57FR8586Final Rule
			Date
			*FR* CitationFinal Rule: No GRASE active ingredients
			4/24/1995
			60FR20162Notice: Availability of guidance on submitting an NDA
			4/28/2004
			69FR23414

Exocrine Pancreatic Insufficiency Drug Products: Nonmonograph Ingredients

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
			5/16/1990
			55FR20434Correction
			6/7/1990
			55FR23235Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			11/7/1990
			55FR46914Correction
			12/3/1990
			55FR49973Technical Amendment: Corrects an ingredient name
			1/30/1992
			57FR3526

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                                                                                  Content current as of:
      06/12/2018Historical Status of OTC Rulemakings
 
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