What Is Compounded Semaglutide?

Compounded semaglutide is a pharmacy-prepared medicine that is not FDA-approved or generic Ozempic or Wegovy. It should be considered only when a patient’s medical need cannot be met by an available approved product and applicable requirements are met.

What compounding means

A pharmacy prepares a medicine for a specific clinical need under applicable requirements. FDA does not review each compounded preparation for safety, effectiveness and quality before marketing as it does an approved product. Source: FDA: risks of compounded medicines

It is not a generic or approved copy

Ozempic and Wegovy have approved formulations and instructions. A compounded preparation containing semaglutide does not inherit that approval. Trial results should not be transferred to a compounded finished product. Source: FDA: unapproved GLP-1 medicines

When it may be considered

FDA recommends compounded drugs only when an available approved medicine cannot meet the medical need. The end of a shortage changes the conditions for making copies; an individual prescription, lower price or added ingredient does not by itself establish an exception. The clinician and pharmacy must assess the requirements for the case. Source: FDA: unapproved GLP-1 medicines

Safety questions for the pharmacy

Confirm the pharmacy’s identity and license, ingredient form, concentration, beyond-use date, storage and exact dose. FDA has warned about errors converting milligrams to volumes or units and about semaglutide salts that differ from the approved ingredient. Do not inject if you do not understand the label. Source: FDA: unapproved GLP-1 medicines

Cost and follow-up

Compare the total payment and follow-up with approved self-pay options. A lower price does not demonstrate equivalence. Clinician-required labs for REMEVi treatment are included. Review semaglutide plans and bring your questions to the evaluation.