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FDA regulatory shifts in 2023 to 2024 moved BPC-157 and other compounds to "Category 2" status, requiring strict 503A/503B medical-grade sourcing for legal clinical use

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A significant proportion of the published work comes from a single research group the Zagreb laboratory associated with Sikiric and colleagues

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This evidence gap is the single largest limitation of peptide-based approaches

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Other sections of the law already included the EU as a reference region

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