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The product is a compounded buccal-dissolve formulation it is not FDA-approved, and the company received an FDA warning letter on February 20, 2026 over labeling and marketing claims
Its mechanisms are broad and systemic, meaning it can benefit tissues throughout the body
What This Means for You: If You're a Prescribing Physician You should not prescribe compounded semaglutide or tirzepatide except in rare circumstances where the individual patient medically requires a compounded alternative to the commercially available drug product
Published online May 24, 2024
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