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It does not appear on the bulks list at 21 CFR 216.23(a), it is no longer in any category of FDA’s interim compounding policy because the nominator withdrew the nomination, and FDA continues to publish the safety concern it identified, stating that BPC-157 “may pose risk for immunogenicity for certain routes of administration” and that “the agency lacks sufficient information to know whether the drug would cause harm when administered to humans.” FDA also convened a vote on BPC-157 at its Pharmacy Compounding Advisory Committee in July 2026, with the agency’s own briefing document recommending against adding it

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[DOI] [PMC free article] [PubMed] [Google Scholar] 9.Levine, A

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