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In September 2023 the FDA placed BPC-157 in Category 2 of its 503A interim bulk-substances policy, citing immunogenicity and peptide-characterization concerns, effectively excluding it from the 503A compounding bulk-substances list

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Adv Drug Deliv Rev 64:640665 Kannan R, Kuhlenkamp JF, Ookhtens M, Kaplowitz N (1992) Transport of glutathione at blood-brain barrier of the rat: inhibition by glutathione analogs and age-dependence