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The 503A Bulks List identifies certain bulk drug substances that may be used in traditional patient-specific compounding when other statutory conditions are satisfied and no applicable monograph or approved-drug-component pathway applies

These commenters stated that the measures provide structured accountability for facility leadership to prioritize equity work, collect data on social determinants of health, and implement quality improvement initiatives

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The data in Table 2 reflect the exposure of 1242 patients with type 2 diabetes to TOUJEO with mean exposure duration of 25 weeks

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