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The FDAs position is unambiguous: BPC-157 "lacks sufficient safety data and has not been shown to be safe or effective in humans." Key implications: Compounding pharmacies cannot legally compound medications containing BPC-157 under Section 503A or 503B Marketing with therapeutic claims violates federal law regardless of disclaimers Warning letters have been issued to companies marketing BPC-157 as a therapeutic agent WADA Prohibition The World Anti-Doping Agency classifies BPC-157 as a prohibited substance under class S0: Non-Approved Substances , effective January 2023

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