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In briefing materials prepared for the July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting, FDA staff proposed that BPC-157 not be added to the Section 503A Bulks List, citing chemical-characterization gaps, insufficient effectiveness evidence for its nominated use (ulcerative colitis - a different indication than NEOLISE's skin/hair marketing), and safety concerns including immunogenicity risk
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10.1074/jbc.274.4.2234 81
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