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FDA reviewers, applying the statutory framework under 21 CFR 216.23(c), identified only one human study for BPC-157's proposed indication of ulcerative colitis: a decades-old meeting abstract that was never published as a peer-reviewed trial and that used an oral route of administration not the injectable or subcutaneous routes that wellness clinics commonly use

Beyond the nervous system, potassium channels serve diverse roles in other tissues

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Endotoxin testing confirms bacterial contamination remains below safety thresholds

The pharmacokinetic rationale is questionable given tirzepatide 5-day half-life

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