Is sermorelin FDA-approved?
The exact status: what was approved, why it was discontinued, and what compounded means for you.
Not today. Sermorelin acetate was sold as Geref, approved in 1997 to treat growth hormone deficiency in children, and discontinued by its maker in 2008. The FDA later determined that Geref was not withdrawn for safety or effectiveness reasons. Sermorelin now is compounded on a patient-specific prescription and is not FDA-approved.
Compounded sermorelin is not FDA-approved; sermorelin was approved as Geref in 1997 and discontinued in 2008.
Opens the Sermorelin application on OpenLoop, in English. Our care team can help in English or Spanish.
Has sermorelin ever had FDA approval?
Yes, as the brand Geref. A diagnostic Geref injection, used to test how the pituitary releases growth hormone, was approved in December 1990. Geref vials for idiopathic growth hormone deficiency in children with growth failure were approved on September 26, 1997. Both applications were held by EMD Serono.
| Product | Use | Approved | Status |
|---|---|---|---|
| Geref 0.05 mg ampule (NDA 19-863) | Diagnostic test of pituitary growth hormone release | December 28, 1990 | Discontinued 2008; approval withdrawn June 18, 2009 |
| Geref 0.5 mg and 1.0 mg vials (NDA 20-443) | Idiopathic growth hormone deficiency in children with growth failure | September 26, 1997 | Discontinued 2008; approval withdrawn June 18, 2009 |
Why was Geref discontinued?
The manufacturer told the FDA in 2008 that it was discontinuing Geref and asked the agency to withdraw the approvals, which took effect June 18, 2009. In 2013 the FDA formally determined that Geref was not withdrawn from sale for reasons of safety or effectiveness, and it stays on the discontinued list.
That determination is about the branded Geref product. It does not make today’s compounded sermorelin an approved drug, and it is not a safety review of any compounded vial.
Does compounded sermorelin have FDA approval?
No. Sermorelin prescribed today is compounded by a state-licensed 503A pharmacy on a patient-specific prescription. The FDA states that compounded drugs are not FDA-approved, which means the agency does not review their safety, effectiveness or quality before they are marketed. It is also not a generic version of Geref.
What “compounded, not FDA-approved” means for you
- A licensed prescriber must evaluate you and write a prescription for you as one patient.
- A licensed 503A compounding pharmacy prepares that prescription; section 503A requires a valid patient-specific prescription.
- No FDA review of the compounded vial: quality depends on the pharmacy’s licensure, its ingredient sources and its sterile practices.
- Vials sold as “research use” without a prescription are outside this framework entirely.
REMEVi works with a state-licensed 503A pharmacy, and a licensed provider reviews your history before deciding whether to prescribe.
What is sermorelin acetate?
Sermorelin acetate is the acetate salt of sermorelin, the form named in Geref’s labeling and in FDA records. Labels often state strength as sermorelin itself: one Geref product listed sermorelin acetate equivalent to 50 micrograms of sermorelin. The salt name does not change the active peptide, which is the same in each.
Safety questions
FDA status and safety are different questions. Whether sermorelin is appropriate for you depends on your health history, the pharmacy that prepares it and clinical follow-up. Our safety guide covers what is known and what is not.
Opens the Sermorelin application on OpenLoop, in English. Our care team can help in English or Spanish.
Sources
- FDA — Determination That GEREF (Sermorelin Acetate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 78 FR 14095 (March 4, 2013) (read November 2, 2026)
- FDA — Orphan Drug Designations and Approvals: sermorelin acetate (Geref) (read November 2, 2026)
- FDA — Understanding the Risks of Compounded Drugs (read November 2, 2026)
- FDA — Human Drug Compounding Laws (read November 2, 2026)
- Irish Medicines Board — Summary of Product Characteristics, Geref 50 (sermorelin acetate), revised May 2004 (read November 2, 2026)
- Healthy Male — Sermorelin: claims, risks and what the evidence shows (read November 2, 2026)
Medically reviewed by Linda West-Conforti, RN · CA RN #389453 ·