FDA Approval
The regulatory determination that a drug's benefits outweigh its risks for a specific use — what separates Wegovy from compounded copies.
FDA approval means a manufacturer proved — through controlled trials, manufacturing inspections, and labeling review — that a specific product is safe and effective for a specific indication. The approval covers the product and use together: Wegovy for chronic weight management, Mounjaro for type 2 diabetes. Prescribing an approved drug outside its indication is "off-label" and legal; selling an unapproved copy is a different matter entirely.
The word's absence is as informative as its presence: compounded semaglutide, research peptides, and supplements are not FDA-approved, and honest sellers say so plainly. The approval letter and prescribing information for any drug are public on the FDA's site — a two-minute check that outranks any marketing page, including this one.
This glossary entry is general information, not medical advice, and is written to be consistent with FDA prescribing information and primary trial publications as of its last review. Always consult a licensed healthcare provider for personal medical decisions.
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