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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 Benign Prostatic Hypertrophy Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Benign Prostatic Hypertrophy Drug Products
  
  	
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    Print**Final Monographs**(21 CFR 310.532)**:***Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy*

**Benign Prostatic Hypertrophy Drug Products**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			10/1/1982
			47FR43566Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			2/20/1987
			52FR5406Correction
			4/14/1987
			52FR12114Correction
			4/30/1987
			52FR15732Final Rule
			Date
			*FR* CitationFinal Monograph: No GRASE active ingredients
			2/27/1990
			55FR6926

                                                                                  Content current as of:
      05/05/2017Historical Status of OTC Rulemakings
 
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