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They exist in a regulatory gray area, often sold with labels that say "for research purposes only." This matters for a few reasons: Quality control is inconsistent

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However, advances in ADC technology and growing clinical demands have broadened its scope beyond cancer

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J Exp Bot 66(10):28392856

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BPC-157 is not FDA-approved and was nominated for, then removed from, 503B bulk-compounding eligibility in 2024 based on FDA's safety review

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