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FDA's stated reasons: Immunogenicity risk — Could trigger immune reactions Impurities — Compounded versions may be contaminated Lack of characterization — Don't fully understand the molecules No human safety data — Haven't been properly tested Reported adverse events — Some have documented side effects The DOJ Prosecution: $1.79 Million Forfeiture In a landmark case, the Department of Justice prosecuted Tailor Made Compounding LLC for distributing unapproved peptides including BPC-157