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Rulemaking History for OTC Laxative Drug Products View by Date
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 |
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 |
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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Date created: December 28, 2006; Updated April 17, 2007 |
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