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  7. Rulemaking History for OTC Laxative Drug Products
  1. 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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