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:

• Original Active Ingredients and Labeling
• Nonmonograph Ingredients
• Bulk Laxatives
• Stimulant Laxatives
• Stool Softener Laxatives
• Saline Laxatives
• Time and Extent Application

Laxative Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	3/21/1975	40FR12902
Reopening of Administrative Record	3/21/1980	45FR18398
Proposed Rule	Date	FR Citation
Tentative Final Monograph	1/15/1985	50FR2124
Correction	2/15/1985	50FR6358
Correction	3/11/1985	50FR9678
Extension of Comment Period	5/15/1985	50FR20235
Amendment (Directions for Bulk Laxatives)	10/1/1986	51FR35136
Reopening of Administrative Record	10/22/2003	68FR60302
Amendment (Sodium Phosphate Salts)	2/11/2011	76FR7743
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Techhnical Amendment: Correct an ingredient name	1/30/1992	57FR3526

Laxative Drug Products: Nonmonograph Ingredients

Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Corrects an ingredient name	1/30/1992	57FR3526

Laxative Drug Products: Bulk Laxatives

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record: Senna and combinations of psyllium and bran	6/2/1992	57FR23174
Proposed Rule	Date	FR Citation
Proposed Rule: Reclassifies danthron and phenolphthalein from category I to category II	9/2/1997	62FR46223
Correction	9/9/1997	62FR47532
Proposed Rule: Reclassifies aloe, bisacodyl, cascara sagrada, and senna from category I to category III	6/19/1998	63FR33592
Final Rule	Date	FR Citation
Final Rule: Reclassifies danthron and phenolphthalein from category I to category II	1/29/1999	64FR4535
Final Rule: Reclassifies aloe and cascara sagrada from category I to category III	5/9/2002	67FR31125
Final Rule: Laxative Drug Products for Over-the-Counter Human Use; Psyllium Ingredients in Granular Dosage Forms	3/29/2007	72FR14669

Laxative Drug Products: Stool Softener Laxatives

Proposed Rule	Date	FR Citation
Proposed Rule: Classifies docusate salts as GRASE active ingredient	9/2/1993	58FR46589

Laxative Drug Products: Saline Laxatives

Proposed Rule	Date	FR Citation
Proposed Rule: Limits package size and adds overdose warnings and directions for sodium phosphate and biphosphate	3/31/1994	59FR15139
Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate	5/21/1998	63FR27886
Proposed Rule: Intent to withdraw 5/21/1998 proposed rule	12/9/1998	63FR67817
Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate	5/21/1998	63FR27886
Proposed Rule: Sodium Labeling for rectal sodium phosphates	3/24/2004	69FR13765
Final Rule	Date	FR Citation
Final Rule: Limits package size and adds overdose warnings and directions for sodium phosphate and biphosphate	5/21/1998	63FR27836
Stay of Compliance Date	12/7/1998	63FR67399
Final Rule: Sodium Labeling for rectal sodium phosphates	11/29/2004	69FR69278

Laxative Drug Products: Time and Extent Applications

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data: Sodium picosulfate	6/22/2006	71FR35917

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