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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 Vaginal Contraceptive Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Vaginal Contraceptive Drug Products
  
  	
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    Print**Pending Final Monograph (21 CFR part 351):**Vaginal Contraceptive Drug Products for Over-the-Counter Human Use**Vaginal Contraceptive Drug Products**Advance Notice Of Proposed RulemakingDate*FR* CitationAdvance Notice of Proposed Rulemaking12/12/198045FR82014Correction2/6/198146FR11292Extension of Comment Period5/5/198146FR25107Proposed RuleDate*FR* CitationProposed Rule: All products are nonmonograph because final formulation effectiveness test needed2/3/199560FR6892Notice: Guidance for development of vaginal contraceptive drugs2/3/199560FR6713Call for Data: Miscellaneous OTC drug products12/31/200368FR75585Notice: Advisory Committee meeting on effectiveness10/30/199661FR55990Reopening of Administrative Record: Advisory Committee meeting12/19/199661FR66953Proposed Rule: Requires warning that products do not protect against STDs1/16/200368FR2254Final RuleDate*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph4/22/199863FR19799Final Rule: Classifies octoxynol 9 as nonmonograph5/9/200267FR31123Final Rule: Required labeling for products containing nonoxynol 912/19/200772FR71769Back to Top

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