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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 Laxative Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Laxative Drug Products
  
  	
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    Print**Pending Final Monograph**(21 CFR part 334)**:*****Laxative Drug Products for Over-the-Counter Human*OTC Laxative Drug Products found on this page:Original Active Ingredients and LabelingNonmonograph IngredientsBulk LaxativesStimulant LaxativesStool Softener LaxativesSaline LaxativesTime and Extent Application**Laxative Drug Products: Original Active Ingredients and Labeling**Advance Notice Of Proposed RulemakingDate*FR* CitationAdvance Notice of Proposed Rulemaking3/21/197540FR12902Reopening of Administrative Record3/21/198045FR18398Proposed RuleDate*FR* CitationTentative Final Monograph1/15/198550FR2124Correction2/15/198550FR6358Correction3/11/198550FR9678Extension of Comment Period5/15/198550FR20235Amendment (Directions for Bulk Laxatives)10/1/198651FR35136Reopening of Administrative Record10/22/200368FR60302Amendment (Sodium Phosphate Salts)2/11/201176FR7743Final RuleDate*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914Correction12/3/199055FR49973Techhnical Amendment: Correct an ingredient name1/30/199257FR3526**Laxative Drug Products: Nonmonograph Ingredients**Proposed RuleDate*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434Correction6/7/199055FR23235Final RuleDate*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914Correction12/3/199055FR49973Technical Amendment: Corrects an ingredient name1/30/199257FR3526**Laxative Drug Products: Bulk Laxatives**Advance Notice Of Proposed RulemakingDate*FR* CitationReopening of Administrative Record: Senna and combinations of psyllium and bran6/2/199257FR23174Proposed RuleDate*FR* CitationProposed Rule: Reclassifies danthron and phenolphthalein from category I to category II9/2/199762FR46223Correction9/9/199762FR47532Proposed Rule: Reclassifies aloe, bisacodyl, cascara sagrada, and senna from category I to category III6/19/199863FR33592Final RuleDate*FR* CitationFinal Rule: Reclassifies danthron and phenolphthalein from category I to category II1/29/199964FR4535Final Rule: Reclassifies aloe and cascara sagrada from category I to category III5/9/200267FR31125Final Rule: Laxative Drug Products for Over-the-Counter Human Use; Psyllium Ingredients in Granular Dosage Forms3/29/200772FR14669**Laxative Drug Products: Stool Softener Laxatives**Proposed RuleDate*FR* CitationProposed Rule: Classifies docusate salts as GRASE active ingredient9/2/199358FR46589**Laxative Drug Products: Saline Laxatives**Proposed RuleDate*FR* CitationProposed Rule: Limits package size and adds overdose warnings and directions for sodium phosphate and biphosphate3/31/199459FR15139Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate5/21/199863FR27886Proposed Rule: Intent to withdraw 5/21/1998 proposed rule12/9/199863FR67817Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate5/21/199863FR27886Proposed Rule: Sodium Labeling for rectal sodium phosphates3/24/200469FR13765Final RuleDate*FR* CitationFinal Rule: Limits package size and adds overdose warnings and directions for sodium phosphate and biphosphate5/21/199863FR27836Stay of Compliance Date12/7/199863FR67399Final Rule: Sodium Labeling for rectal sodium phosphates11/29/200469FR69278**Laxative Drug Products: Time and Extent Applications**Advance Notice Of Proposed RulemakingDate*FR* CitationRequest for Data: Sodium picosulfate6/22/200671FR35917Back to Top

                                                                                  Content current as of:
      07/10/2017Historical Status of OTC Rulemakings
 
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