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It is primarily marketed and sold for research purposes only, and its regulatory status indicates that it is not regulated by the FDA or similar bodies for human use

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Over the past two decades, BPC-157 has become one of the most studied peptides in the repair and recovery research space, with over 100 published studies exploring its effects across a wide range of tissue types

These modifications are also believed to assist at least 90% of the peptide to bind covalently to blood albumin, with trace amounts potentially binding to fibrinogen and immunoglobulin G (IgG)

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Its compounding-pathway status shifted in April 2026 when the FDA removed it from Category 2 of the 503A bulk substances list, though this is a compounding determination, not an approval