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The STEP program, published in NEJM in 2021, studied semaglutide for weight management across defined populations and endpoints
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FDA procedurally removed it from Category 2 in April 2026 after nominators withdrew their submissions and referred it to the Pharmacy Compounding Advisory Committee, which is scheduled to review it on July 23-24, 2026 for possible inclusion on the approved 503A bulks list
Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with semaglutide
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While compounded medications are not FDA-approved, they are prepared by licensed pharmacies following strict regulatory guidelines
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