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FDA regulatory context: As of May 2026, the FDA has proposed excluding compounded semaglutide and tirzepatide from the 503B Bulks List, with a public comment period closing June 29, 2026

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If you have patients with biopsy-confirmed or imaging-suggested MASH especially those with obesity, type 2 diabetes, or metabolic syndrome there may be a meaningful option for them beyond standard lifestyle counseling

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