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The FDA has flagged BPC-157 because of risks like immunogenicity (it could trigger immune reactions), peptide impurities, and lack of human safety data
[8] Although not an absolute contraindication, patients with coronary artery disease or unstable angina should only use B-Complex injections containing niacinamide under physician supervision, since high-dose niacin supplements have been linked to arrhythmias in such patients
(The 503A Bulks List is a list of drug substances that the FDA has approved for compounding under section 503A of the Federal Food, Drug, and Cosmetic Act.) If the peptides meet the safety requirements, the committee will recommend reclassifying them onto this list, so they can then be legally prescribed and compounded