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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 Smoking Deterrent Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Smoking Deterrent Drug Products
  
  	
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    Print**Final Monographs**(21 CFR 310.544)**:***Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent*

OTC Smoking Deterrent Drug Products found on this page:

Original Active Ingredients and Labeling
	Nonmonograph Ingredients**Smoking Deterrent Drug Products: Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			1/5/1982
			47FR490Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			7/3/1985
			50FR27552Extension of Comment Period
			7/17/1986
			51FR25899Final Rule
			Date
			*FR* CitationFinal Rule: No GRASE active ingredients
			6/1/1993
			58FR31236



**Smoking Deterrent 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

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                                                                                  Content current as of:
      10/04/2017Historical Status of OTC Rulemakings
 
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