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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Benign Prostatic Hypertrophy Drug Products
  1. Historical Status of OTC Rulemakings

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