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In briefing materials prepared for the July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting, FDA staff proposed that the reviewed forms of BPC-157, KPV, and TB-500 not be added to the Section 503A Bulks List, citing chemical-characterization gaps, insufficient effectiveness evidence for their nominated uses (which, for BPC-157, was ulcerative colitis - a different indication than NEOLISE's skin/hair marketing), and safety concerns
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