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in 2026 that nomination was withdrawn and BPC-157 was removed from Category 2, but the FDA has proposed against adding it to the 503A bulks list, so it remains unauthorized for compounding rather than cleared for it

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Potential risks include: Infection risk if injections are administered in non-clinical settings without appropriate sterile technique Allergic reactions to any component of the formulation Liver toxicity theoretical concern with excessive methionine or choline Drug interactions particularly if combined with other supplements or medications Unknown long-term effects due to absence of longitudinal safety data The MHRA advises caution with unlicensed injectable products, as quality, purity, and sterility cannot be guaranteed