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The peptide's unusual gastric stabilitysurviving extreme pH conditionsdistinguishes it from most peptides, but in solution it remains susceptible to oxidation, hydrolysis, and bacterial contamination

On July 23 and 24, the FDA's Pharmacy Compounding Advisory Committee (PCAC) met to consider whether certain peptides, including TB-500, should be added to the 503A Bulks List, which is a list of drug substances that the FDA has approved for compounding

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