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They added BPC-157 to Category 2 of substances presenting significant safety risks, noting concerns about immune reactions, peptide impurities, and lack of safety data for any human use

D. C. Morris, M. Chopp, L. Zhang, and Z. G. Zhang, Thymosin 4: a candidate for treatment of stroke?, Wiley, May 2010. doi: 10.1111/j.1749-6632.2010.05469.x