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The FDA has also flagged BPC-157 as a bulk drug substance that may present significant safety risks when used in compounding, noting limited safety information and concerns like immunogenicity for certain routes of administration and peptide-related impurities

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"We can choose to build on the foundation that peptides like BPC-157n have given us and find a responsible way forward - one where patients stay under a clinician's care, where that care is monitored and studied, and where we steadily get better at how we use these therapies in the service of human health," Anant Vinjamoori, Hims' chief medical officer, said at Thursday's meeting