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Metabolic Health

Semaglutide: approved medicines and unapproved versions

A regulatory guide to branded FDA-approved medicines, compounded preparations, and unapproved products.

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Educational information only — not medical advice. This material cannot diagnose a condition, recommend treatment, or replace care from a qualified clinician who knows your history. The Peptide Center uses an evidence-first editorial process that prioritizes primary regulatory sources, trial registries, and peer-reviewed research; uncertainty and evidence limits should be part of every health claim.

FDA-approved semaglutide medicines have specific labeled indications and are reviewed as complete products. A compounded preparation is not FDA approved, and an unapproved product marketed as semaglutide has not undergone FDA review for safety, effectiveness, or quality. Approval of one product does not transfer to another source or formulation. See the FDA safety information.

External sources and citations

  1. FDA's concerns with unapproved GLP-1 drugs used for weight loss
  2. Compounding and the FDA: Questions and Answers

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