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U.S. Department of Health and Human Services


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