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 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC Anticaries Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Anticaries Drug Products
  
  	
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    Print**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*CitationAdvance Notice Of Proposed Rulemaking
			3/28/1980
			45FR20666Correction
			5/20/1980
			45FR33650Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			9/30/1985
			50FR39854Correction
			10/24/1985
			50FR43233Extension of Comment Period
			2/21/1989
			54FR7448Final Rule
			Date
			*FR* CitationFinal Monograph
			10/6/1995
			60FR52474Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning
			10/7/1996
			61FR52285

**Anticaries Drug Products: Nonmonograph Ingredients**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
			5/16/1990
			55FR20434Correction
			6/7/1990
			55FR23235Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			11/7/1990
			55FR46914Correction
			12/3/1990
			55FR49973Technical Amendment: Corrects an ingredient name
			1/30/1992
			57FR3526

**Anticaries Drug Products: Final Formulation Testing**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationPublic Meeting
			8/26/1983
			48FR38853Extension of Comment Period
			10/25/1983
			48FR49304Proposed Rule
			Date
			*FR* CitationProposed Rule
			6/15/1988
			53FR22430Extension of Comment Period
			2/21/1989
			54FR7448Final Rule
			Date
			*FR* CitationFinal Monograph
			10/6/1995
			60FR52474Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning
			10/7/1996
			61FR52285

**Anticaries Drug Products: Fluoride Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationReopening of Administrative Record
			11/24/1992
			57FR55199Extension of Comment Period
			1/26/1993
			58FR6102Final Rule
			Date
			*FR* CitationFinal Monograph
			10/6/1995
			60FR52474Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning
			10/7/1996
			61FR52285

**Anticaries Drug Products: Intraoral Appliance Models**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: To comply with biological testing requirements
			10/15/2001
			66FR52418Reopening of Comment Period
			3/15/2002
			67FR11704

**Package Size Limitation**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationReopening of Administrative Record
			5/8/1992
			57FR19823Correction
			5/19/1992
			57FR21332Final Rule
			Date
			*FR* CitationFinal Monograph
			10/6/1995
			60FR52474Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning
			10/7/1996
			61FR52285

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                                                                                  Content current as of:
      02/04/2020Historical Status of OTC Rulemakings
 
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