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                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 Ophthalmic Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Ophthalmic Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 349)**:***Ophthalmic Drug Products for Over-the-Counter Human Use*OTC Ophthalmic Drug Products found on this page:Original Active Ingredients and LabelingEmergency First Aid EyewashesContact Lens SolutionVasoconstrictor Warning**Ophthalmic Drug Products: Original Active Ingredients and Labeling**Advance Notice Of Proposed RulemakingDate*FR* CitationAdvance Notice of Proposed Rulemaking5/6/198045FR30002Correction7/22/198045FR48920Proposed RuleDate*FR* CitationTentative Final Monograph6/28/198348FR29788Correction7/19/198348FR32837Reopening of Administrative Record: Yellow mercuric oxide (anti-infective) excluded from      final monograph3/4/198853FR6997Final RuleDate*FR* CitationFinal Monograph3/4/198853FR7076Correction4/21/198853FR13217Technical Amendment: Revises "hydroxypropyl methylcellulose" to "hypromellose"6/3/200368FR32981Technical Amendment: Clarifies Labeling of Active/Inactive Ingredients2/19/200368FR7919**Ophthalmic Drug Products: Emergency First Aid Eyewashes**Advance Notice Of Proposed RulemakingDate*FR* CitationRequest or Data12/5/198954FR50240Proposed RuleDate*FR* CitationProposed Rule2/19/200368FR7951Final RuleDate*FR* Citation**Ophthalmic Drug Products: Contact Lens Solution**Advance Notice Of Proposed RulemakingDate*FR* CitationNotice: Reclassifies contact lens solution from OTC drug to device3/6/197944FR12270**Ophthalmic Drug Products: Vasoconstrictor Warning**Proposed Amendment of Final MonographDate*FR* CitationProposed Amendment of Final Monograph2/23/199863FR8888**Amendment of Final Monograph****Date*****FR* Citation**Amendment of Final Monograph6/21/200065FR38426Back to Top

                                                                                  Content current as of:
      07/24/2017Historical Status of OTC Rulemakings
 
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