Drugs

Rulemaking History for OTC Anticaries Drug Products

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

FDA Archive-It webpage:

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OTC Anticaries Drug Products found on this page:

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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