U.S. Food and Drug Administration (FDA)
Is Sermorelin legal in United States?
Compounding restrictedPreviously FDA-approved as Geref (now discontinued, not for safety reasons); sermorelin acetate can be compounded only under 503A/503B conditions
Pharmacy-made copies are tightly limited.
Sermorelin acetate was FDA-approved as Geref, but Drugs@FDA lists Geref as discontinued, and in 2013 FDA determined it was not withdrawn for reasons of safety or effectiveness. Because it is a component of a previously approved drug, sermorelin acetate can be used by 503A pharmacies without being on the bulks list, and FDA's March 2025 503B list includes it in Category 1 (marked as a component of an approved drug). Compounders must still meet the other 503A and 503B conditions, and promotion of compounded products as approved or equivalent is a target of FDA enforcement.
Last verified 2026-09-29 · how we verify
Sermorelin elsewhere
Sources (5)
- 01Drugs@FDA data via openFDA: GEREF (sermorelin acetate) applications, marketing statusU.S. Food and Drug Administration · 2026-09-24 · accessed 2026-09-29
- 02Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessFederal Register (FDA) · 2013-03-04 · accessed 2026-09-29
- 03Bulk Drug Substances Nominated for Use in Compounding Under Section 503B (Categories 1, 2 and 3)U.S. Food and Drug Administration · 2025-03-21 · accessed 2026-09-29
- 04Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. Food and Drug Administration · 2026-05-14 · accessed 2026-09-29
- 05FDA to Telehealth Companies: What to Know When Promoting Compounded DrugsU.S. Food and Drug Administration · 2026-06-15 · accessed 2026-09-29