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Compounded drugs can be important for overcoming shortages or meeting unique patient needsbut compounders should not try to compound drugs in a way that circumvents FDA's approval process." 1 What Specific Violations and Commercial Risks Has the FDA Identified

Until human clinical trials validate BPC157s safety and effectiveness, and until regulatory bodies approve pharmaceutical-grade versions, it remains a biologically active but legally and clinically dicey regarding human injection

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