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Arch Immunol Ther Exp (Warsz) 2023, 71 (1), 16.10.1007/s00005-023-00682-z [DOI] [PMC free article] [PubMed] 35.A

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For BPC-157 specifically, the regulatory posture tightened in 2023, when the FDA placed BPC-157 in Category 2 of its interim 503A bulk-drug-substances list the category for substances that the agency judges to raise significant safety concerns a placement that in practice barred licensed compounding pharmacies from preparing it under that pathway

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