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compounded tirzepatide is prepared by licensed pharmacies using bulk API (active pharmaceutical ingredient) under USP standards but without product-level FDA approval
However, the majority of research has been conducted in animals, and more comprehensive human studies are needed to establish its long-term safety
doi: 10.1056/NEJM199901143400204 275
Though changes to the process do happen, it is vital to have a change control process in place, according to Nagpal
Safety : Semaglutide is FDA-approved, ensuring federal standards for safety and effectiveness have been met
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