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The stated rationale was safety concerns, though many clinicians and compounding pharmacy groups argued the agency overstepped, noting that no specific safety signal justified the restriction for most of the affected peptides

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The FDA's Pharmacy Compounding Advisory Committee evaluated BPC-157 at its July 2026 meeting, and the accompanying briefing document concluded that the criteria weigh against adding it to the compounding bulks list, citing poor chemical characterization, insufficient evidence of effectiveness, and insufficient human safety data