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It was placed on the FDAs 503A Category 2 bulk-substances list in September 2023, a designation that restricted its use in pharmacy compounding

Substantial published clinical research from Metabolic Pharmaceuticals' formal pharmaceutical development program (Phase 1, 2, and IIb trials)

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Understanding Bacteriostatic Water in Peptide Reconstitution Bacteriostatic water for injection contains 0.9% benzyl alcohol to inhibit bacterial growth, allowing multi-dose use, but it is not routinely available as a licensed product in the UK and must not be used in neonates

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