Rulemaking History for OTC Benign Prostatic Hypertrophy Drug Products

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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]10/1/198247FR43566
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]2/20/198752FR5406
    Correction [PDF]4/14/198752FR12114
    Correction [PDF]4/30/198752FR15732
Final RuleDateFR Citation
Final Monograph: No GRASE active ingredients [PDF]2/27/199055FR6926


Page Last Updated: 04/06/2016
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