Drug Products Containing Quinine for the Treatment and/or Prevention of Malaria for Over-the-Counter Human Use

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The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) drug products containing quinine for the treatment and/or prevention of malaria are not generally recognized as safe and are misbranded. FDA is issuing this final rule after considering public comment on the agency's notice of proposed rulemaking and all data and information that have come to the agency's attention on the safety of quinine.