# Is sermorelin FDA approved, and is it legal?
Updated November 3, 2026. Canonical: https://try-astra.com/sermorelin/guides/fda-approved-legal/

**Sermorelin at Astra:** $91/mo on the 6-month plan ($546 every 6 months) or $120/mo on the monthly plan. Includes medication, provider visit, supplies and shipping. Full refund if a provider does not prescribe. Pay by card or Apple Pay, or over time with Klarna, Afterpay or Affirm at checkout. Prescription required. Compounded medications are not FDA-approved. [Start a visit](https://start.try-astra.com/start-online-visit/sermorelin).

## 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A brand version, Geref, was once FDA-approved, was discontinued by its maker, and in 2013 FDA determined it was [not withdrawn for reasons of safety or effectiveness](https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm). FDA's [May 14, 2026 list](https://www.fda.gov/media/94164/download) 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.

**Considering sermorelin?** A licensed provider reviews your answers and decides whether it is appropriate. See how it compares on price in the [sermorelin price index](/sermorelin-price-index/), or read about the [sermorelin program](/sermorelin/). [Start your sermorelin visit](https://start.try-astra.com/start-online-visit/sermorelin).
$120 charged monthly, or $546 every 6 months ($91/mo). Renews automatically; cancel any time. Full refund if a provider does not prescribe. [Subscription terms](/subscription-terms/).

## The 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](https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm) |
| September 26, 1997 | Geref 0.5 mg and 1.0 mg approved, for GH deficiency in children with growth failure | [Federal Register](https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm) |
| 2008 | The maker told FDA both products were being discontinued | [Federal Register](https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm) |
| March 4, 2013 | FDA determined they were not withdrawn for safety or effectiveness, which allows FDA to approve generic applications if other requirements are met | [Federal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](https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm) |
| 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](https://www.fda.gov/media/94164/download) |
| October 28, 2026 | HHS's draft peptide policy covers six peptides. [Sermorelin is not one of them](/news/hhs-peptide-compounding-policy/) | [Astra's summary](/news/hhs-peptide-compounding-policy/) |

## 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](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)) | FDA restricts bulk use to its 503B list or shortage list, with an interim policy for Category 1 substances ([FDA](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503b-fdc-act)) |
| Sermorelin on FDA's lists | Not named on the [503A nominations list](https://www.fda.gov/media/94155/download) | Category 1, marked as a component of FDA-approved drugs ([FDA list](https://www.fda.gov/media/94164/download)) |

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](/sermorelin/guides/online-prescription/).
- **Use in tested sports.** The [World Anti-Doping Agency's 2025 Prohibited List](https://www.wada-ama.org/sites/default/files/2024-09/2025list_en_final_clean_12_september_2024.pdf) 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](https://www.deadiversion.usdoj.gov/drug_chem_info/hgh.pdf). Sermorelin is a different drug. See [sermorelin vs HGH](/sermorelin/guides/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](https://www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/locate-state-licensed-online-pharmacy) 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](https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm). 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](/sermorelin/guides/online-prescription/).

### 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](/news/hhs-peptide-compounding-policy/).

### Is sermorelin banned in sports?
Yes, for athletes under anti-doping rules. It is named on the [WADA Prohibited List](https://www.wada-ama.org/sites/default/files/2024-09/2025list_en_final_clean_12_september_2024.pdf).

## 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](https://www.wada-ama.org/sites/default/files/2024-09/2025list_en_final_clean_12_september_2024.pdf). Read [is sermorelin safe?](/sermorelin/guides/is-it-safe/) for sources and details.

## Keep reading

- [All sermorelin guides](/sermorelin/guides/)
- [Sermorelin online](/sermorelin/guides/online-prescription/): Why a licensed US provider beats a research-peptide seller, and how it works.
- [Is sermorelin safe?](/sermorelin/guides/is-it-safe/): Known side effects, who should avoid it, and what remains unknown.
- [Providers compared](/sermorelin/guides/providers-compared/): Six providers' prices as printed on their own pages, and what to check beyond price.
- [Sermorelin vs tesamorelin](/sermorelin/guides/vs-tesamorelin/): FDA status, evidence and safety compared, with no head-to-head trial to rely on.

**More guides:** [Does sermorelin work?](/sermorelin/guides/does-it-work/) · [Results timeline](/sermorelin/guides/results-timeline/) · [Sermorelin for women](/sermorelin/guides/for-women/) · [Sermorelin and weight loss](/sermorelin/guides/weight-loss/) · [Sermorelin vs CJC-1295](/sermorelin/guides/vs-cjc-1295/) · [Sermorelin vs HGH](/sermorelin/guides/vs-hgh/) · [Sermorelin and sleep](/sermorelin/guides/sleep/) · [Sermorelin with GLP-1s](/sermorelin/guides/with-tirzepatide-or-semaglutide/) · [Stopping sermorelin](/sermorelin/guides/stopping/)

## Sources

- [Determination that Geref was not withdrawn for safety or effectiveness](https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm), Federal Register, March 4, 2013
- [503B nominated bulk drug substances list, updated May 14, 2026](https://www.fda.gov/media/94164/download), FDA
- [503A nominated bulk drug substances list, updated May 14, 2026](https://www.fda.gov/media/94155/download), FDA
- [Bulk drug substances used in compounding under section 503A](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act), FDA
- [Bulk drug substances used in compounding under section 503B](https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503b-fdc-act), FDA
- [2025 Prohibited List](https://www.wada-ama.org/sites/default/files/2024-09/2025list_en_final_clean_12_september_2024.pdf), World Anti-Doping Agency
- [Human Growth Hormone drug fact sheet](https://www.deadiversion.usdoj.gov/drug_chem_info/hgh.pdf), US Drug Enforcement Administration
- [Locate a state-licensed online pharmacy](https://www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/locate-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.