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In this section: Historical 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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