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Patient safety & quality control Compounded GLP-1 drugs have had quality variability and even unsafe/illegal versions in the market FDA is trying to ensure patients get standardized, approved formulations This aligns with FDAs core principle: approved drugs = known safety, dosing, manufacturing controls 2) Prevents copycat mass production Compounding is legally meant for special cases, not large-scale alternatives The GLP-1 boom led to industrial-scale compounding (especially via telehealth) FDA is essentially saying: this has gone beyond its intended use To me, it should be done in combination with large scale initiatives to significantly improve access and affordability
in PIONEER 5, 55.1% of patients failed screening
Reconstitute in sterile PBS pH 7.4 supplemented with 0.1% BSA
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