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In September 2023, the FDA placed both on its Category 2 list of bulk substances that raise significant safety risks (FDA, 2023)
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PCAC review (July 2026) The FDA stated it intends to consult the Pharmacy Compounding Advisory Committee on July 23, 2026 regarding inclusion of BPC-157 acetate and BPC-157 (free base) on the 503A bulks list
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