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But whats getting the spotlight right now are more than a dozen unapproved peptide drugs that, back in September 2023, the FDA added to its Category 2 Bulk Substances listthats a list of substances that the FDA says pose significant safety risks and are not eligible for compounding without further research

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That puts them squarely in the third category, meaning their legal use in compounding hinges almost entirely on whether they make it onto the 503A Bulks List