FDA status
Ozempic and compounded semaglutide are not the same regulatory product
Ozempic is an FDA-approved branded finished drug with manufacturer-specific formulations, indications, evidence, and instructions. A patient-specific compounded semaglutide prescription follows a separate prescriber-and-pharmacy pathway and should not be described as Ozempic, an FDA-approved finished drug, a generic, an equivalent, or an interchangeable substitute.
- Ask which exact semaglutide product is being discussed, why it fits your diagnosis or goal, and whether Ozempic, Wegovy, or a compounded path is being considered.
- Compounded medications require clinician oversight, pharmacy transparency, patient-specific labeling, storage instructions, and follow-up plans.
- FDA has warned about risks with unapproved GLP-1 products, dosing errors, salt-form confusion, and products sold outside legitimate prescription channels.