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In this section: Historical Status of OTC Rulemakings

Rulemaking History for OTC Anticaries Drug Products

Final Monograph (21 CFR part 355):
Anticaries Drug Products for Over-the-Counter Human Use

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

Anticaries Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice Of Proposed Rulemaking	3/28/1980	45FR20666
Correction	5/20/1980	45FR33650
Proposed Rule	Date	FR Citation
Tentative Final Monograph	9/30/1985	50FR39854
Correction	10/24/1985	50FR43233
Extension of Comment Period	2/21/1989	54FR7448
Final Rule	Date	FR Citation
Final Monograph	10/6/1995	60FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning	10/7/1996	61FR52285

Anticaries 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

Anticaries Drug Products: Final Formulation Testing

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Public Meeting	8/26/1983	48FR38853
Extension of Comment Period	10/25/1983	48FR49304
Proposed Rule	Date	FR Citation
Proposed Rule	6/15/1988	53FR22430
Extension of Comment Period	2/21/1989	54FR7448
Final Rule	Date	FR Citation
Final Monograph	10/6/1995	60FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning	10/7/1996	61FR52285

Anticaries Drug Products: Fluoride Labeling

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	11/24/1992	57FR55199
Extension of Comment Period	1/26/1993	58FR6102
Final Rule	Date	FR Citation
Final Monograph	10/6/1995	60FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning	10/7/1996	61FR52285

Anticaries Drug Products: Intraoral Appliance Models

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data: To comply with biological testing requirements	10/15/2001	66FR52418
Reopening of Comment Period	3/15/2002	67FR11704

Package Size Limitation

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	5/8/1992	57FR19823
Correction	5/19/1992	57FR21332
Final Rule	Date	FR Citation
Final Monograph	10/6/1995	60FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning	10/7/1996	61FR52285

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