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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 10/1/1982 47FR43566disclaimer icon
Proposed Rule Date FR Citation
Tentative Final Monograph 2/20/1987 52FR5406disclaimer icon
    Correction 4/14/1987 52FR12114disclaimer icon
    Correction 4/30/1987 52FR15732disclaimer icon
Final Rule Date FR Citation
Final Monograph: No GRASE active ingredients 2/27/1990 55FR6926disclaimer icon

Page Last Updated: 02/21/2017
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