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Off-label use

Prescribing a medication for a condition or in a manner not officially FDA-approved.

Updated Sep 26, 2026

Off-label use refers to prescribing an FDA-approved drug for a purpose, dose, or population outside what it was officially approved for. This is legal and common in medicine, but insurers often will not cover off-label prescriptions — a relevant issue for GLP-1 drugs approved for diabetes but prescribed for weight loss, or vice versa, depending on the specific product's approval.

Source: FDA (external link).

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    Related terms

    • Semaglutide salt forms — Versions of semaglutide such as semaglutide sodium and semaglutide acetate, which the FDA says are different active ingredients from the semaglutide base used in approved drugs, with no known lawful basis for compounding.
    • Open enrollment — The annual window when you can enroll in or change your health plan, and the time to compare GLP-1 coverage across the plans available to you.
    • P&T committee (Pharmacy and Therapeutics committee) — The panel of physicians, pharmacists, and other clinicians that reviews the clinical evidence behind a plan's formulary: which drugs are acceptable, which are interchangeable, and what restrictions apply.
    • API (active pharmaceutical ingredient) — The raw drug substance in a medication that produces its effect — for example, semaglutide itself, before it is formulated into a pen or vial.
    • Certificate of analysis (CoA) — A document reporting the lab test results for a specific batch of a drug ingredient or product, such as identity, purity, and contaminants.

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