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U.S. Department of Health and Human Services

Drugs

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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 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

Anticaries Drug Products: Nonmonograph Ingredients
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

Anticaries Drug Products: Final Formulation Testing
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

Anticaries Drug Products: Fluoride Labeling
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

Anticaries Drug Products: Intraoral Appliance Models
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

Package Size Limitation
Advance Notice Of Proposed Rulemaking Date FR Citation
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

Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning [PDF]

10/7/1996 61FR52285