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The FDA makes the final decision

FAQ: TB-500 vs BPC-157 Are TB-500 and BPC-157 the same thing

The component-resolved HPLC panel, the multi-target LC-MS run, the ICP copper measurement, and the LAL endotoxin assay all have to clear against pre-locked criteria before the lot is signed off, with a partial pass on any single assay triggering a hold rather than conditional release