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Three tiers apply: Tier 1: US-Licensed Compounding Pharmacy (2022 and Earlier) Prior to the FDA's 2022 restriction, 503A compounding pharmacies could prepare sterile BPC-157 injections under cGMP-adjacent standards with pharmacist oversight, sterility testing, and physician prescribing
Need for Robust Human Clinical Trials: Large-scale, randomized, placebo-controlled human clinical trials are indispensable
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