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Here the API appears in Category I of the Bulks list, or has a USP Monograph, or is a component of an FDA-approved drug, is a dietary supplement peptide, comes from FDA-registered facilities, is accompanied with a Certificate of Analysis, and is compounded in compliance with USP 785 or 797

in December 2024 the FDA's Pharmacy Compounding Advisory Committee voted against adding it to the final 503A bulks list, citing nonclinical toxicity, an unresolved cardiac signal, and immunogenicity risk

TB-500 (10mg) is a synthetic version of a 43-amino-acid segment of thymosin beta-4, a protein present in most animal cells