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Key implications: The Category-2 prohibition by name is gone, and the compounding pathway is a recommendation rather than a rule Compounding still constitutes unapproved new drug manufacturing under the FD&C Act, the floor that applies to all non-monograph peptides 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