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In the United States, compounded medications are not FDA-approved

Allergic reactions, including serious hypersensitivity, have been reported rarely

This decision reinforces the importance of using FDA-approved medications to ensure patient safety and quality

Even at the maximum tirzepatide dose, the pyridoxine delivery stays well below 50 mg, far under the 100 mg daily tolerable upper limit established by the National Institutes of Health

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According to an agency press release issued Tuesday, the enforcement action centers on telehealth firms that marketed compounded versions of semaglutide, tirzepatide and liraglutide products, in ways that suggested equivalence with FDA-approved therapies such as Wegovy, Ozempic, Mounjaro and Zepbound