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U.S. Department of Health and Human Services


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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 [PDF] 10/1/1982 47FR43566
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 2/20/1987 52FR5406
    Correction [PDF] 4/14/1987 52FR12114
    Correction [PDF] 4/30/1987 52FR15732
Final Rule Date FR Citation
Final Monograph: No GRASE active ingredients [PDF] 2/27/1990 55FR6926