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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Laxative Drug Products
  1. Historical Status of OTC Rulemakings

Rulemaking History for OTC Laxative Drug Products

Pending Final Monograph (21 CFR part 334):  
Laxative Drug Products for Over-the-Counter Human

OTC Laxative Drug Products found on this page:

Laxative Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking3/21/197540FR12902
    Reopening of Administrative Record3/21/198045FR18398
Proposed RuleDateFR Citation
Tentative Final Monograph1/15/198550FR2124
   Correction2/15/198550FR6358
   Correction3/11/198550FR9678
   Extension of Comment Period5/15/198550FR20235
Amendment (Directions for Bulk Laxatives)10/1/198651FR35136
Reopening of Administrative Record10/22/200368FR60302
Amendment (Sodium Phosphate Salts)2/11/201176FR7743
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
   Techhnical Amendment: Correct an ingredient name1/30/199257FR3526

Laxative Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
    Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526

Laxative Drug Products: Bulk Laxatives

Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record: Senna and combinations of psyllium and bran6/2/199257FR23174
Proposed RuleDateFR Citation
Proposed Rule: Reclassifies danthron and phenolphthalein from category I to category II9/2/199762FR46223
   Correction9/9/199762FR47532
Proposed Rule: Reclassifies aloe, bisacodyl, cascara sagrada, and senna from category I to category III6/19/199863FR33592
Final RuleDateFR Citation
Final Rule: Reclassifies danthron and phenolphthalein from category I to category II1/29/199964FR4535
Final Rule: Reclassifies aloe and cascara sagrada from category I to category III5/9/200267FR31125
Final 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 RuleDateFR Citation
Proposed Rule: Classifies docusate salts as GRASE active ingredient9/2/199358FR46589

Laxative Drug Products: Saline Laxatives

Proposed RuleDateFR Citation
Proposed Rule: Limits package size and adds overdose warnings and directions for sodium phosphate and biphosphate3/31/199459FR15139
Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate5/21/199863FR27886
Proposed Rule: Intent to withdraw 5/21/1998 proposed rule12/9/199863FR67817
Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate5/21/199863FR27886
Proposed Rule: Sodium Labeling for rectal sodium phosphates3/24/200469FR13765
Final RuleDateFR Citation
Final Rule: Limits package size and adds overdose warnings and directions for sodium phosphate and biphosphate5/21/199863FR27836
    Stay of Compliance Date12/7/199863FR67399
Final Rule: Sodium Labeling for rectal sodium phosphates11/29/200469FR69278

Laxative Drug Products: Time and Extent Applications

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Sodium picosulfate6/22/200671FR35917

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