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Section 503A of the Federal Food, Drug, and Cosmetic Act governs state-licensed pharmacies and physicians preparing medications for identified individual patients

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The authors identified a previously uncharacterized impurity, an adduct formed by a chemical reaction between tirzepatide and B12, present at significant levels and absent from FDA-approved tirzepatide

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Any decision must weigh preliminary, mostly animal-based evidence against unknown human risks, and that calculus belongs to you and your physician, not to a marketing page