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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
Lee's stance: "The FDA has not prohibited physicians from prescribing these agents." Legal experts disagree: Healthcare attorney David Holt: "It is likely not legal for compounding pharmacies to provide BPC-157." The Medical Freedom Argument Peptide advocates say: Risk vs
Zhu L, Wu Y, Chen Y, Chen X, Zan X, Liu Y, Geng W
There are very few instances where this treatment would not be a viable option
For consistency, reproducibility, and batch comparability, only the recommended diluent system should be used unless an alternative solvent is specifically stated in the product documentation
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