Sermorelin guide 路 Updated November 3, 2026
Is sermorelin FDA approved, and is it legal?
What FDA's own documents say about sermorelin's approval history and compounding status. This is general information, not legal advice.
.md Read this page as Markdown (for AI assistants)The short answer
Compounded sermorelin is not FDA-approved. A brand version, Geref, was once FDA-approved, was discontinued by its maker, and in 2013 FDA determined it was not withdrawn for reasons of safety or effectiveness. FDA's May 14, 2026 list marks sermorelin acetate as a component of FDA-approved drugs, which is relevant to compounding, but that does not make any compounded product FDA-approved.
Get it through a licensed US provider
A prescription, a state-licensed US pharmacy, and a care team. You get a full refund if it is not prescribed.
Start your sermorelin visitThe FDA timeline
| Date | What happened | Source |
|---|---|---|
| December 28, 1990 | Geref 0.05 mg approved, for testing the pituitary's ability to release growth hormone | Federal Register |
| September 26, 1997 | Geref 0.5 mg and 1.0 mg approved, for GH deficiency in children with growth failure | Federal Register |
| 2008 | The maker told FDA both products were being discontinued | Federal Register |
| March 4, 2013 | FDA determined they were not withdrawn for safety or effectiveness, which allows FDA to approve generic applications if other requirements are met | Federal Register |
| May 14, 2026 | FDA's 503B list places sermorelin acetate in Category 1 and marks it as a component of FDA-approved drugs | FDA list |
| October 28, 2026 | HHS's draft peptide policy covers six peptides. Sermorelin is not one of them | Astra's summary |
How compounding rules apply
There are two kinds of compounder, with different rules on which bulk ingredients they can use.
| 503A pharmacy | 503B outsourcing facility | |
|---|---|---|
| What it is | A state-licensed pharmacy compounding for an individual patient's prescription | A facility registered with FDA as an outsourcing facility |
| Bulk ingredient rule | The ingredient must meet a USP or NF monograph, be a component of an FDA-approved drug, or be on FDA's 503A list (FDA) | FDA restricts bulk use to its 503B list or shortage list, with an interim policy for Category 1 substances (FDA) |
| Sermorelin on FDA's lists | Not named on the 503A nominations list | Category 1, marked as a component of FDA-approved drugs (FDA list) |
Some online sources read sermorelin's absence from the 503A nominations list as a restriction. FDA's 503A page also allows components of FDA-approved drugs, which is the marking FDA gives sermorelin acetate on its 503B list. FDA's 503B list also says it does not intend to take action over the "essentially a copy" condition for a copy of an approved drug that has been discontinued and is no longer marketed, a statement about outsourcing facilities. How these rules apply to a specific product is a legal question for the pharmacy and its counsel, and FDA can update these lists.
What to avoid
- Products labelled for research use. These are not prescriptions prepared for you as a patient. See how to tell the difference.
- Use in tested sports. The World Anti-Doping Agency's 2025 Prohibited List names sermorelin among substances prohibited at all times.
- Treating it as the same as HGH. The DEA describes off-label anti-aging prescribing of HGH as illegal. Sermorelin is a different drug. See sermorelin vs HGH.
What to ask any provider
- Which pharmacy fills the prescription, and is it licensed in my state?
- Is it a 503A pharmacy or a 503B outsourcing facility?
- Will the product be prepared on a prescription for me, and does it come with a pharmacy label?
- Does the provider say clearly that the medication is not FDA-approved?
You can check a pharmacy's license using FDA's state-by-state resource.
Common questions
Why was sermorelin discontinued?
The maker of Geref told FDA in 2008 that it was discontinuing the products. In 2013 FDA determined they were not withdrawn for reasons of safety or effectiveness. The notice we read does not give the maker's reason.
Is it legal to buy sermorelin online?
Getting it with a valid prescription through a licensed provider and pharmacy is the established route. Rules can vary, so this is general information rather than legal advice. See how a prescription works.
Is sermorelin a controlled substance?
We did not confirm a federal controlled-substance listing for this page. Ask your provider or pharmacist if this matters for you.
Is sermorelin covered by the HHS peptide policy?
No. The October 2026 draft policy covers six other peptides.
Is sermorelin banned in sports?
Yes, for athletes under anti-doping rules. It is named on the WADA Prohibited List.
Safety at a glance
Reported side effects include flushing, injection site pain or irritation and mild headache. Sermorelin is not recommended in pregnancy or breastfeeding, active cancer or certain pituitary conditions, and long-term safety in adults has not been established. It is prohibited in tested sports. Read is sermorelin safe? for sources and details.
Keep reading
- All sermorelin guides
- Sermorelin online: Why a licensed US provider beats a research-peptide seller, and how it works.
- Is sermorelin safe?: Known side effects, who should avoid it, and what remains unknown.
- Providers compared: Six providers' prices as printed on their own pages, and what to check beyond price.
- Sermorelin vs tesamorelin: FDA status, evidence and safety compared, with no head-to-head trial to rely on.
More guides: Does sermorelin work? 路 Results timeline 路 Sermorelin for women 路 Sermorelin and weight loss 路 Sermorelin vs CJC-1295 路 Sermorelin vs HGH 路 Sermorelin and sleep 路 Sermorelin with GLP-1s 路 Stopping sermorelin
Sources
- Determination that Geref was not withdrawn for safety or effectiveness, Federal Register, March 4, 2013
- 503B nominated bulk drug substances list, updated May 14, 2026, FDA
- 503A nominated bulk drug substances list, updated May 14, 2026, FDA
- Bulk drug substances used in compounding under section 503A, FDA
- Bulk drug substances used in compounding under section 503B, FDA
- 2025 Prohibited List, World Anti-Doping Agency
- Human Growth Hormone drug fact sheet, US Drug Enforcement Administration
- Locate a state-licensed online pharmacy, FDA
Published by Astra, which offers sermorelin. This guide is educational and is not medical advice. Compounded medications are not FDA-approved and are not reviewed by the FDA for safety, effectiveness or quality.
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