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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 Nailbiting and Thumbsucking Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Nailbiting and Thumbsucking Drug Products
  
  	
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    Print**Final Monograph**(21 CFR 310.536)**:***Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent*

Original Active Ingredients and Labeling
	Nonmonograph Ingredients**Nailbiting and Thumbsucking Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			10/17/1980
			45FR69122Correction
			12/23/1980
			45FR84836Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			9/3/1982
			47FR39096Correction
			11/19/1982
			47FR52200Final Rule
			Date
			*FR* CitationFinal Monograph: No GRASE active ingredients
			9/2/1993
			58FR46749

**Nailbiting and Thumbsucking 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
			57FR3526Back to Top

                                                                                  Content current as of:
      02/28/2022Historical Status of OTC Rulemakings
 
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