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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 Oral Healthcare Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Oral Healthcare Drug Products
  
  	
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    Print**Pending Final Monograph** (21 CFR part 356)**:*****Oral Health Care Drug Products for Over-the-Counter Human Use* OTC Oral Healthcare Drug Products found on this page: Anesthetic, Astringent, Antimicrobial, Debriding, Demulcent, Expectorant, Decongestant     Antigingivitis/Antiplaque     Oral Antiseptic     Toothache Relief, Tooth Desensitizer, Oral Mucosal Analgesic, Oral Mucosal Protectant     Nonmonograph Ingredients**** **Oral Healthcare Drug Products: Anesthetic, Astringent, Antimicrobial, Debriding, Demulcent, Expectorant, Decongestant** Advance Notice Of Proposed Rulemaking             Date             *FR* CitationAdvance Notice of Proposed Rulemaking             5/25/1982             47FR22760Extension of Comment Period             7/30/1982             47FR32953Correction             10/15/1982             47FR46117Extension of Comment Period             12/28/1982             47FR57738Proposed Rule             Date             *FR* CitationTentative Final Monograph             1/27/1988             53FR2436Correction             3/17/1988             53FR8845Proposed Rule: Exempts menthol lozenges from accidental overdose warning             5/13/1992             57FR20434Correction             6/25/1992             57FR28555Correction             7/9/1992             57FR30534Correction             7/27/1992             57FR33237**Oral Healthcare Drug Products: Antigingivitis/Antiplaque** Advance Notice Of Proposed Rulemaking             Date             *FR* CitationRequest for Data             9/19/1990             55FR38560Correction             10/9/1990             55FR41170Extension of Comment Period             3/8/1991             56FR9915Notice:  Advisory Committee meeting             9/19/1994             59FR47880Advance Notice of Proposed Rulemaking             5/29/2003             68FR32232Extension of Comment Period             8/25/2003             68FR50991Correction             10/6/2003             68FR57642Notice: Availability of Draft Guidance on development and evaluation of these drug products                  Guidance             6/28/2005             70FR37102Extension of Comment Period: Gingivitis claims             8/24/2005             70FR49660Request for Data: Triclosan time and extent application             7/6/2004             69FR40640 **Oral Healthcare Drug Products: Oral Antiseptic** Advance Notice Of Proposed Rulemaking             Date             *FR* CitationAdvance Notice of Proposed Rulemaking             5/25/1982             47FR22760Extension of Comment Period             7/30/1982             47FR32953Proposed Rule             Date             *FR* CitationProposed Rule             2/9/1994             59FR6084Correction             3/14/1994             59FR11836**Oral Healthcare Drug Products: Toothache Relief, Tooth Desensitizer, Analgesic, Protectant** Advance Notice Of Proposed Rulemaking             Date             *FR* CitationAdvance Notice of Proposed Rulemaking             5/25/1982             47FR22712Proposed Rule             Date             *FR* CitationProposed Rule             9/24/1991             56FR48302Correction             12/19/1991             56FR 65930 **Oral Healthcare 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 Back to Top

                                                                                  Content current as of:
      06/07/2017Historical Status of OTC Rulemakings
 
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