Drugs
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: Bulk Laxatives | Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|
| Reopening of Administrative Record: Senna and combinations of psyllium and bran [PDF] | 6/2/1992 | 57FR23174 |
| Proposed Rule | Date | FR Citation |
|---|
| Proposed Rule: Reclassifies danthron and phenolphthalein from category I to category II [PDF] | 9/2/1997 | 62FR46223 |
| Correction [PDF] | 9/9/1997 | 62FR47532 |
| Proposed Rule: Reclassifies aloe, bisacodyl, cascara sagrada, and senna from category I to category III [PDF] | 6/19/1998 | 63FR33592 |
| Final Rule | Date | FR Citation |
|---|
| Final Rule: Reclassifies danthron and phenolphthalein from category I to category II [PDF] | 1/29/1999 | 64FR4535 |
| Final Rule: Reclassifies aloe and cascara sagrada from category I to category III [PDF] | 5/9/2002 | 67FR31125 |
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 [PDF] | 3/31/1994 | 59FR15139 |
| Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate [PDF] | 5/21/1998 | 63FR27886 |
| Proposed Rule: Intent to withdraw 5/21/1998 proposed rule [PDF] | 12/9/1998 | 63FR67817 |
| Proposed Rule: Adds professional labeling for sodium phosphate and biphosphate [PDF] | 5/21/1998 | 63FR27886 |
| Proposed Rule: Sodium Labeling for rectal sodium phosphates [PDF] | 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 [PDF] | 5/21/1998 | 63FR27836 |
| Stay of Compliance Date [PDF] | 12/7/1998 | 63FR67399 |
| Final Rule: Sodium Labeling for rectal sodium phosphates [PDF] | 11/29/2004 | 69FR69278 |
Laxative Drug Products: Time and Extent Applications| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|
| Request for Data: Sodium picosulfate [PDF] | 6/22/2006 | 71FR35917 |
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