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[DOI] [PMC free article] [PubMed] [Google Scholar] 12.Poston L., Briley A., Seed P., Kelly F., Shennan A

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This means any pharmacy compounding BPC-157 is producing an unapproved drug, which is a violation of federal law unless it falls within one of the narrow statutory exemptions, and the absence of the substance from both Category 1 and Category 2 makes that exemption argument extremely difficult to sustain

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