Drugs

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:

Anticaries Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice Of Proposed Rulemaking3/28/198045FR20666disclaimer icon
   Correction5/20/198045FR33650disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph9/30/198550FR39854disclaimer icon
   Correction10/24/198550FR43233disclaimer icon
Extension of Comment Period2/21/198954FR7448disclaimer icon
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 nonmonograph5/16/199055FR20434disclaimer icon
   Correction6/7/199055FR23235disclaimer icon
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914disclaimer icon
   Correction12/3/199055FR49973disclaimer icon
   Technical Amendment: Corrects an ingredient name1/30/199257FR3526disclaimer icon

Anticaries Drug Products: Final Formulation Testing

Advance Notice Of Proposed RulemakingDateFR Citation
Public Meeting8/26/198348FR38853disclaimer icon
   Extension of Comment Period10/25/198348FR49304disclaimer icon
Proposed RuleDateFR Citation
Proposed Rule6/15/198853FR22430disclaimer icon
   Extension of Comment Period2/21/198954FR7448disclaimer icon
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 Record11/24/199257FR55199disclaimer icon
   Extension of Comment Period1/26/199358FR6102disclaimer icon
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 Record5/8/199257FR19823disclaimer icon
   Correction5/19/199257FR21332disclaimer icon
Final RuleDateFR Citation
Final Monograph10/6/199560FR52474
Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning10/7/199661FR52285

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