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The statute itself is silent on what constitutes essentially copies of a commercially available drug product, but the FDA has interpretated the term broadly

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Regulatory Oversight & Quality Name brand GLP1s like Ozempic/Wegovy (semaglutide) and Mounjaro/Zepbound (tirzepatide) are: FDA-approved after rigorous trials demonstrating safety and consistent dosing Manufactured to biotech standards, ensuring sterility and ingredient verification By contrast, compounded GLP1 medications are mixed in pharmacies, often from powders or salts

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Nearly all participants lost at least 5% of their body weight, and roughly 60% reached their weight loss target of 20% or more