For 503A pharmacies, the FDA confirmed a narrow enforcement safe harbor: the agency does not currently intend to take action against pharmacies that compound an essentially-a-copy GLP-1 product, provided they fill no more than four prescriptions of that preparation per calendar month
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But the papers authors, including researchers at Case Western Reserve University and Nora Volkow, the director of the National Institute on Drug Abuse, cautioned that the link between GLP-1 drugs and prevention of overdose deaths is unclear and that more research is needed, including randomized controlled trials
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