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

Rulemaking History for OTC Antimalarial Drug Products

Final Monograph (21 CFR 310.547):
Drug Products Containing Quinine Offered Over-the-Counter (OTC) for the Treatment and/or Prevention of Malaria

Antimalarial Drug Products 

Proposed Rule Date FR Citation
Proposed Rule: No GRASE active ingredients 4/19/1995 60FR19650
    Correction 5/2/1995 60FR21590
Final Rule Date FR Citation
Final Rule: No GRASE active ingredients 3/20/1998 63FR13526
Notice: Enforcement Action 12/15/2006  71FR75557
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