Rulemaking History for OTC Laxative Drug Products
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 |