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Patient Safety Data Driving the Posture The FDAs enforcement posture is anchored in accumulated adverse event data: 455+ adverse event reports linked to compounded semaglutide as of early 2025 (current counts higher) 320+ adverse event reports linked to compounded tirzepatide as of early 2025 (current counts higher) Many reports involve dosing errors from patients self-administering incorrect amounts from multidose vials Several reports document hospitalization following severe nausea, dehydration, or pancreatitis Concerns about counterfeit products entering supply chains through online channels Cold-chain integrity issues with compounded shipments arriving warm or with inadequate temperature controls Salt-form substitution risks products containing semaglutide acetate or sodium rather than semaglutide base used in FDA-approved products These data points feature prominently in FDA communications and the Federal Register notice rationale

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GLP-1 Receptor Agonists and the Path to Sustainable Obesity Care