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This compound is not approved as a drug, diagnostic, or dietary ingredient, and is not manufactured, packaged, or marketed for human consumption, self-experimentation, clinical application, or any use outside properly designed and ethically approved research protocols.

The FDA issued a notice in 2023 indicating BPC-157 cannot be compounded under section 503A or 503B of the Federal Food, Drug, and Cosmetic Act because it does not appear on approved bulk substance lists

These claimed benefits are still experimental and have not been proven in large human trials

the dosage is determined by the milligrams (mg) listed on the label

Safety advice BPC 157 is not an approved treatment for most medical conditions, and quality and sterility standards vary by supplier