Frequently Asked Questions by Consumers on Quinine Sulfate:
Q: May I purchase Quinine Sulfate?
A. Federal law (21 C.F.R. §§ 310.546, 310.547) prohibits over-the-counter sale of quinine or quinine salts for the treatment and/or prevention of leg cramps or malaria. The FDA deems any “OTC drug product [containing quinine or quinine salts] that is labeled, represented, or promoted” for the treatment and/or prevention of nocturnal leg muscle cramps or malaria to be a “new drug within the meaning of the [Food, Drug, and Cosmetic Act].” “In the absence of an approved new drug application or abbreviated new drug application, such product is misbranded under [the FD&C] Act.”
In 2005, the FDA approved Quinine Sulfate Capsules USP, 324 mg, manufactured by Mutual Pharmaceutical Co., as a prescription-only drug for the treatment of malaria. These capsules are not approved for any other indication, including relief from leg cramps.