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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 Otic Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Otic Drug Products
  
  	
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    Print**Final Monograph** (21 CFR part 344)**:***Topical Otic Drug Products for Over-the-Counter Human Use*
**OTC Otic Drug Products found on this page:**
Original Active Ingredients and Labeling
    Swimmer's Ear and Water-Clogged Ears
    Nonmonograph Ingredients**Otic Drug Products: Original Active Ingredients and Labeling**
Advance Notice Of Proposed Rulemaking
            Date
            *FR* CitationAdvance Notice of Proposed Rulemaking
            12/16/1977
            42FR63556Correction
            12/12/1978
            43FR58097Reopening of Administrative Record
            3/21/1980
            45FR18401Proposed Rule
            Date
            *FR* CitationTentative Final Monograph
            7/9/1982
            47FR30012Correction
            8/13/1982
            47FR35249Final Rule
            Date
            *FR* CitationFinal Monograph
            8/8/1986
            51FR28656Correction
            3/13/1987
            52FR7830**Otic Drug Products: Swimmer's Ear and Water-Clogged Ears**
Proposed Rule
            Date
            *FR* CitationProposed Rule: Includes labeling but no GRASE active ingredients
            7/30/1986
            51FR27366Correction
            11/25/1986
            51FR42676Proposed Rule: Revises 2/15/1995 to include labeling and GRASE active ingredient for water-clogged ears
            8/17/1999
            64FR44671Final Rule
            Date
            *FR* CitationFinal Rule: No GRASE active ingredients
            2/15/1995
            60FR8916Correction
            4/6/1995
            60FR17611Correction
            4/28/1995
            60FR20897Stay: Water-clogged ears
            8/16/1995
            60FR42435Final Rule: Includes labeling and GRASE active ingredients for water-clogged ears
            8/10/2000
            65FR48902**Otic 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

                                                                                  Content current as of:
      01/23/2017Historical Status of OTC Rulemakings
 
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