FDA proposes to remove ephedrine OTC status citing abuse, misuse concerns.
• By The Tan Sheet
EPHEDRINE WITHDRAWAL FROM OTC STATUS PROPOSED BY FDA in a July 27 Federal Register notice. FDA said the notice of proposed rulemaking was issued "in response to a request from the U.S. Department of Justice's Drug Enforcement Administration to restrict OTC availability of ephedrine" because of its use in the illicit manufacturing of controlled substances such as methamphetamine and methcathinone, and due to the potential for misuse and abuse of OTC ephedrine drug products.
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