Drugs
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Rulemaking History for OTC Anticaries Drug Products
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Final Monograph (21 CFR part 355): |
OTC Anticaries Drug Products found on this page:
- Original Active Ingredients and Labeling
- Nonmonograph Ingredients
- Final Formulation Testing
- Fluoride Labeling
- Intraoral Appliance Models
- Package Size Limitation
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Advance Notice Of Proposed Rulemaking [PDF] | 3/28/1980 | 45FR20666 |
| Correction [PDF] | 5/20/1980 | 45FR33650 |
| Proposed Rule | Date | FR Citation |
| Tentative Final Monograph [PDF] | 9/30/1985 | 50FR39854 |
| Correction [PDF] | 10/24/1985 | 50FR43233 |
| Extension of Comment Period [PDF] | 2/21/1989 | 54FR7448 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 10/6/1995 | 60FR52474 |
| Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning [PDF] | 10/7/1996 | 61FR52285 |
| Proposed Rule | Date | FR Citation |
|---|---|---|
| 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: Corrects an ingredient name [PDF] | 1/30/1992 | 57FR3526 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Public Meeting [PDF] | 8/26/1983 | 48FR38853 |
| Extension of Comment Period [PDF] | 10/25/1983 | 48FR49304 |
| Proposed Rule | Date | FR Citation |
| Proposed Rule [PDF] | 6/15/1988 | 53FR22430 |
| Extension of Comment Period [PDF] | 2/21/1989 | 54FR7448 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 10/6/1995 | 60FR52474 |
| Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning [PDF] | 10/7/1996 | 61FR52285 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Reopening of Administrative Record [PDF] | 11/24/1992 | 57FR55199 |
| Extension of Comment Period [PDF] | 1/26/1993 | 58FR6102 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 10/6/1995 | 60FR52474 |
| Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning [PDF] | 10/7/1996 | 61FR52285 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
|---|---|---|
| Request for Data: To comply with biological testing requirements [PDF] | 10/15/2001 | 66FR52418 |
| Reopening of Comment Period [PDF] | 3/15/2002 | 67FR11704 |
| Advance Notice Of Proposed Rulemaking | Date | FR Citation |
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| Reopening of Administrative Record [PDF] | 5/8/1992 | 57FR19823 |
| Correction [PDF] | 5/19/1992 | 57FR21332 |
| Final Rule | Date | FR Citation |
| Final Monograph [PDF] | 10/6/1995 | 60FR52474 |
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Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning [PDF] |
10/7/1996 | 61FR52285 |
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