No: sermorelin is not FDA-approved as of this update. It once was. FDA approved two Geref products in 1990 and 1997, the maker discontinued them in 2008, and the approvals were withdrawn in 2009 [3]. In 2013 FDA found that the products "were not withdrawn from sale for reasons of safety or effectiveness" [2].
No: sermorelin is not FDA-approved today
The reviewed current DailyMed query identified no sermorelin label [5]. FDA’s historical notices establish the two Geref withdrawals. A current ingredient query returned the discontinued diagnostic application; a limited database query should not be presented as an exhaustive history of every application or proof about possible generic products [4].
That makes sermorelin different from most peptides sold for longevity. It has a real approval history, with human data reviewed by FDA. It just isn't an approved drug anymore.
The approvals: 1990 and 1997, for two narrow uses
FDA approved Geref Diagnostic on December 28, 1990 (NDA 19-863), to test whether the pituitary can release growth hormone. It approved Geref for injection on September 26, 1997 (NDA 20-443), to treat idiopathic growth hormone deficiency in children with growth failure [2]. EMD Serono held both.
The therapeutic approval covered children with growth failure, not adult wellness uses such as aging, body composition or sleep. The treatment approval rested on children: in a one-year open-label study of 110 treated growth-hormone-deficient children, with 86 in the efficacy analysis, mean height velocity rose from 1.6 inches (4.1 cm) a year to 3.1 inches (8.0 cm) at six months and 2.8 inches (7.2 cm) at twelve months [10].
Discontinued in 2008, withdrawn in 2009
EMD Serono told FDA in July and December 2008 that it was discontinuing both Geref products, and asked FDA to withdraw the two applications [2]. FDA's withdrawal notice was published May 19, 2009 (74 FR 23407), as part of a list of 92 new drug applications, and took effect June 18, 2009 [3].
| Date | What happened |
|---|---|
| December 28, 1990 | FDA approves Geref Diagnostic, NDA 19-863 [2] |
| August 26, 1991 | FDA approves a 12-to-24-month shelf-life extension for the historical Geref product at 45°F (7°C); it is not a stability study of today’s compounded products [1] |
| September 26, 1997 | FDA approves Geref for pediatric growth hormone deficiency, NDA 20-443 [2] |
| July 11, 2008 | EMD Serono tells FDA it is discontinuing Geref Diagnostic [2] |
| December 2, 2008 | EMD Serono discontinues Geref and asks FDA to withdraw NDA 20-443 [2] |
| December 12, 2008 | EMD Serono asks FDA to withdraw NDA 19-863 [2] |
| May 19, 2009 | Federal Register notice withdrawing both approvals [3] |
| June 18, 2009 | Withdrawal takes effect [3] |
| October 12, 2012 | A citizen petition asks FDA whether Geref was withdrawn for safety reasons [2] |
| March 4, 2013 | FDA publishes its finding: not withdrawn for safety or effectiveness [2] |
| March 21, 2025 | FDA's 503B list shows sermorelin acetate in Category 1, under evaluation [8] |
| Now | No label identified in the reviewed DailyMed query; no sermorelin entry in the current 503A nomination categories [5] [7] |
2013: FDA said the withdrawal wasn't about safety
The Food and Drug Administration (FDA) has determined that GEREF (Sermorelin Acetate) injection … and GEREF (Sermorelin Acetate) injection … were not withdrawn from sale for reasons of safety or effectiveness.[2]
FDA’s determination permits generic applications referencing Geref if all other requirements are met [2]. The determination itself is not a generic approval, and a current compounded product does not become approved because it contains the same ingredient.
So "withdrawn" here means the maker walked away, not that FDA pulled an unsafe drug. It also doesn't mean FDA approves sermorelin today. Both halves matter, and pages that report only one of them mislead.
So what sermorelin do providers prescribe?
Sermorelin prescribed by telehealth providers today is compounded by pharmacies. It is not an FDA-approved product, and FDA does not review compounded drugs for safety, effectiveness or quality before they are sold [6].
Two FDA lists are relevant, and they say different things. On the 503A list, which covers state-licensed compounding pharmacies, sermorelin is in no category at all [7]. On the 503B list, which covers larger outsourcing facilities, sermorelin acetate sits in Category 1, "under evaluation", and is marked as a component of an FDA-approved drug [8].
Absence from nomination categories is not the entire 503A analysis. FDA also describes routes based on an applicable compendial monograph or an approved-drug component, along with other statutory conditions. Neither a historical ingredient approval nor a Category 1 entry automatically makes every preparation lawful. Confirm the specific pharmacy, prescription and state requirements [12].
| Version | FDA-approved? | Who makes it | How it reaches you | What it means for you |
|---|---|---|---|---|
| Geref (brand) | Was approved (1990, 1997); withdrawn 2009 | EMD Serono | No longer sold | Not available |
| Compounded, 503A pharmacy | No FDA-approved finished compounded product | State-licensed compounding pharmacy | Prescription from a licensed prescriber | Quality depends on the pharmacy; ask which one fills it |
| Compounded, 503B outsourcing facility | No; on FDA's 503B list, Category 1 (under evaluation) | Outsourcing facility registered with FDA | Through a prescriber or clinic | Still not an approved product; ask which facility made it |
| “Research use only” vial | No | Seller offering research materials | Research supply, not a patient-prescription pathway | The label is not evidence that contents are suitable for administration to people |
Status as of this update, from Drugs@FDA, FDA's 503A and 503B lists and the Federal Register.
Is sermorelin a steroid?
Sermorelin is a peptide growth-hormone-releasing factor, not an anabolic steroid or growth hormone itself [10]. Its prescription and product-approval questions are separate from sport rules.
In sport it is a different story. WADA's Prohibited List names sermorelin under S2.2.4, growth hormone releasing factors, prohibited at all times [9].
| Claim | What the record shows | Verdict |
|---|---|---|
| "Sermorelin is an FDA-approved peptide" | Historical approvals were withdrawn; today’s compounded preparations are not FDA-approved [3]. | Misleading |
| "It was withdrawn, so it must be unsafe" | FDA found in 2013 that Geref was not withdrawn for safety or effectiveness reasons [2] | False |
| "It was discontinued in 2006" | EMD Serono discontinued the products in 2008; the withdrawal took effect in 2009 [2] | Wrong date |
| "It reverses aging" | 11 older men for six weeks: no change in IGF-1, weight, or DEXA muscle and fat; 2 of 6 strength tests improved [11] | Unproven |
| “The old FDA finding approves my generic product” | The 2013 determination allows applications if other requirements are met; it does not itself approve a generic or compounded product [2] | Unsupported inference |
What to ask a prescriber before you start
Because the current product is compounded and adult wellness uses are not FDA-approved, the useful questions are about the pharmacy and the plan, not the brand name.
- Which pharmacy compounds my sermorelin, and is it a 503A pharmacy or a 503B outsourcing facility?
- Why sermorelin for me? What is it meant to change, and how will we know?
- Which labs will you check before I start and while I'm on it?
- What happens if I stop, and when would you advise stopping?
For the safety side of that conversation, see whether sermorelin is safe. For contrast, tesamorelin is a related GHRH analog that is still FDA-approved, for one narrow use.
How to check a sermorelin provider
Start with the fine print, not the homepage. Look for the pharmacy's name, whether it is a 503A or 503B facility, who the prescriber is, and what the plan costs after the first month. Our provider checks for CoreAge Rx, AgelessRx and Strut Health set out what each one says on those points. The checks we run are described on how we check.