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 RulemakingDateFR Citation
Advance Notice Of Proposed Rulemaking3/28/198045FR20666
   Correction5/20/198045FR33650
Proposed RuleDateFR Citation
Tentative Final Monograph]9/30/198550FR39854
   Correction10/24/198550FR43233
Extension of Comment Period2/21/198954FR7448
Final RuleDateFR Citation
Final Monograph10/6/199560FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning10/7/199661FR52285

Anticaries Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
   Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
   Correction12/3/199055FR49973
   Technical Amendment: Corrects an ingredient name1/30/199257FR3526

Anticaries Drug Products: Final Formulation Testing

Advance Notice Of Proposed RulemakingDateFR Citation
Public Meeting8/26/198348FR38853
   Extension of Comment Period10/25/198348FR49304
Proposed RuleDateFR Citation
Proposed Rule6/15/198853FR22430
   Extension of Comment Period2/21/198954FR7448
Final RuleDateFR Citation
Final Monograph10/6/199560FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning10/7/199661FR52285

Anticaries Drug Products: Fluoride Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record11/24/199257FR55199
   Extension of Comment Period1/26/199358FR6102
Final RuleDateFR Citation
Final Monograph10/6/199560FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning10/7/199661FR52285

Anticaries Drug Products: Intraoral Appliance Models

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: To comply with biological testing requirements10/15/200166FR52418
   Reopening of Comment Period3/15/200267FR11704

Package Size Limitation

Advance Notice Of Proposed RulemakingDateFR Citation
Reopening of Administrative Record5/8/199257FR19823
   Correction5/19/199257FR21332
Final RuleDateFR Citation
Final Monograph10/6/199560FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning10/7/199661FR52285

 

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