After spending time on the FDA's Category 2 list flagged for "significant safety concerns" BPC-157 is now being removed from that restrictive classification and scheduled for a Pharmacy Compounding Advisory Committee (PCAC) review on July 23, 2026
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In 2023, the FDA designated BPC-157 as a Category 2 bulk drug substance, meaning it cannot be compounded by commercial pharmaceutical companies, and there is insufficient evidence regarding potential harm to humans