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The FDA's Pharmacy Compounding Advisory Committee (PCAC) is scheduled to review TB-500 in July 2026 for possible placement on the 503A Bulks List (Category 1)

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Every batch includes: HPLC purity analysis chromatographic confirmation of 99% single-peak purity Mass spectrometry identity verification confirming the correct 1,419.53 Da molecular weight Amino acid analysis sequence verification of the 15-residue GEPPPGKPADDAGLV sequence QR code COA verification every product vial includes a QR code linking to the lot-specific COA, enabling point-of-use analytical verification BPC-157 is available in research-ready lyophilized format