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U.S. Department of Health and Human Services

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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 Rulemaking [PDF]3/21/197540FR12902
    Reopening of Administrative Record [PDF]3/21/198045FR18398
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]1/15/198550FR2124
    Correction [PDF]2/15/198550FR6358
    Correction [PDF]3/11/198550FR9678
    Extension of Comment Period [PDF]5/15/198550FR20235
Amendment (Directions for Bulk Laxatives) [PDF]10/1/198651FR35136
Reopening of Administrative Record [PDF]10/22/200368FR60302
Amendment (Sodium Phosphate Salts)2/11/201176FR7743
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
   Techhnical Amendment: Correct an ingredient name [PDF]1/30/199257FR3526
 
Laxative Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name [PDF]1/30/199257FR3526
 
Laxative Drug Products: Bulk Laxatives
Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record: Senna and combinations of psyllium and bran [PDF]6/2/199257FR23174
Proposed RuleDateFR Citation
Proposed Rule: Reclassifies danthron and phenolphthalein from category I to category II [PDF]9/2/199762FR46223
    Correction [PDF]9/9/199762FR47532
Proposed Rule: Reclassifies aloe, bisacodyl, cascara sagrada, and senna from category I to category III [PDF]6/19/199863FR33592
Final RuleDateFR Citation
Final Rule: Reclassifies danthron and phenolphthalein from category I to category II [PDF]1/29/199964FR4535
Final Rule: Reclassifies aloe and cascara sagrada from category I to category III [PDF]5/9/200267FR31125

Laxative Drug Products: Stool Softener Laxatives
Proposed RuleDateFR Citation
Proposed Rule: Classifies docusate salts as GRASE active ingredient [PDF]9/2/199358FR46589

Laxative Drug Products: Saline Laxatives
Proposed RuleDateFR Citation
Proposed Rule: Limits package size and adds overdose warnings and directions for sodium phosphate and biphosphate [PDF]3/31/199459FR15139
Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate [PDF]5/21/199863FR27886
Proposed Rule: Intent to withdraw 5/21/1998 proposed rule [PDF]12/9/199863FR67817
Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate [PDF]5/21/199863FR27886
Proposed Rule: Sodium Labeling for rectal sodium phosphates [PDF]3/24/200469FR13765
Final RuleDateFR Citation
Final Rule: Limits package size and adds overdose warnings and directions for sodium phosphate and biphosphate [PDF]5/21/199863FR27836
    Stay of Compliance Date [PDF]12/7/199863FR67399
Final Rule: Sodium Labeling for rectal sodium phosphates [PDF]11/29/200469FR69278
 
Laxative Drug Products: Time and Extent Applications
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Sodium picosulfate [PDF]6/22/200671FR35917