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Recent FDA effortsto crack down on unapproved GLP-1 productsthat arebeingmass-marketed by compounding pharmaciesandtelehealthplatformsare a critical step toward protecting patients' safety and well-being.These effortsmust continue against unlawful mass compounding of tirzepatidethat puts patients at risk, including companiesthatsell compounded tirzepatidecombinedin the same solutionwithuntested additives such as B12

Translational challenges for these agents are also discussed, particularly the need to understand how the timing of treatment may influence outcomes

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Protecting consumers from false and misleading claims about compounded drugs is a priority for CDER

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