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BPC-157 is not universally appropriate

It contains 0.9% benzyl alcohol that inhibits bacterial growth in the solution, supporting up to 28 days of refrigerated use per vial

Low potassium levels (hypokalemia) This may occur after rapid correction of severe B12 deficiency

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