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 RuleDateFR Citation
Proposed Rule: No GRASE active ingredients4/19/199560FR19650
Final RuleDateFR Citation
Final Rule: No GRASE active ingredients3/20/199863FR13526
Notice: Enforcement Action12/15/2006 71FR75557

Page Last Updated: 02/23/2017
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