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 Rulemaking10/1/198247FR43566
Proposed RuleDateFR Citation
Tentative Final Monograph2/20/198752FR5406
Final RuleDateFR Citation
Final Monograph: No GRASE active ingredients2/27/199055FR6926

Page Last Updated: 05/05/2017
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