Sermorelin

Regulatory status

There is no FDA-approved product containing this substance currently marketed in the U.S. The absence of a marketed approved product does not establish availability or lawful compounding eligibility. Compounding frameworks include section 503A of the Federal Food, Drug, and Cosmetic Act (by a state-licensed pharmacy or physician, for an individual patient who has a patient-specific prescription) and section 503B (by an FDA-registered outsourcing facility), each with separate requirements. Neither pathway is FDA approval: the FDA does not review 503A or 503B compounded drugs for safety, effectiveness or quality before they reach patients, and a compounded drug is never confirmed to be the same in safety or effectiveness as an FDA-approved drug or a generic. Legal access depends on which pathway applies — a 503A product generally requires a prescription written for you specifically, while a 503B product is purchased by a licensed prescriber or facility from a registered outsourcing facility — not on general public sale.