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10.1016/0024-3205(82)90039-x 121 VlisidesP

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Removal from Category 2 does not guarantee long-term regulatory acceptance, nor does it replace the need for clinical judgment, proper sourcing, and compliance with federal and state guidelines

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