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"We have 10 years of supervised patient use." Yet other physicans urged the FDA committee to consider the lack of clinical evidence

10.1016/j.archger.2009.07.001 72

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For BPC-157 to be compounded under 503A, it must be formally added to the FDA's positive bulk drugs list, which requires a favorable recommendation from the Pharmacy Compounding Advisory Committee (PCAC) followed by formal rulemaking