Is compounded sermorelin FDA-approved for anti-aging or wellness?

Compounded sermorelin is not FDA-approved. Compounded medications are prepared by a licensed pharmacy for one patient. The FDA does not review these medications for safety, effectiveness, or quality before they are marketed. A prescription does not change that approval status.

Sermorelin is used off-label in some wellness programs. Off-label refers to using a drug outside its approved labeling. However, calling a use off-label does not mean the compounded product itself has FDA approval. Evidence that sermorelin reverses aging or provides broad wellness benefits is limited. Results vary. Claims that it restores youth or guarantees better health should be treated with caution.

A licensed physician in your state decides whether treatment is appropriate for you. That decision should include a review of your symptoms, medical history, other medicines, and available alternatives. Ask why a compounded medication is being considered and what risks come with it. You should also know what follow-up is planned and what would lead your physician to stop treatment.