Rulemaking History for OTC Antidiarrheal Drug Products
Final Monograph (21 CFR part 335):
Antidiarrheal Drug Products for Over-the-Counter Human Use
OTC Antidiarrheal Drug Products found on this page:
Antidiarrheal Drug Products: Original Active Ingredients and Labeling
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 3/21/1975 | 40FR12902 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 4/30/1986 | 51FR16138 |
| Correction [PDF] | 7/21/1986 | 51FR26170 |
| Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 5/16/1990 | 55FR20434 |
| Correction [PDF] | 6/7/1990 | 55FR23235 |
| Final Rule | Date | FR Citation |
| Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] | 11/7/1990 | 55FR46914 |
| Correction [PDF] | 12/3/1990 | 55FR49973 |
| Technical Amendment: Correct an ingredient name [PDF] | 1/30/1992 | 57FR3526 |
| Final Monograph[PDF] | 4/17/2003 | 68FR18869 |
| Correction[PDF] | 6/26/2003 | 68FR37963 |
Antidiarrheal Drug Products: Bismuth Subsalicylate
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice of Proposed Rulemaking [PDF] | 3/21/1975 | 40FR12902 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule: Adds Travelers' diarrhea indication [PDF] | 4/17/2003 | 68FR18915 |
| Final Rule | Date | FR Citation |
| Final Rule: Adds Travelers' diarrhea indication [PDF] | 5/12/2004 | 69FR26301 |
Antidiarrheal Drug Products: Time and Extent Application
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Request for Data: Saccharomyces boulardii [PDF] | 8/23/2004 | 69FR51852 |
| Notice of Withdrawal: Saccharomyces boulardii | 10/27/2009 | 74FR55245 |