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Sermorelin & Men’s Health
5 min read
Updated Oct 28, 2026.
No. The sermorelin prescribed today is compounded, and compounded drugs are not FDA-approved. A brand version did hold FDA approval once. Below: what was approved, why it ended, what compounding means, and how to check a pharmacy.
The short answer
Question | Answer |
|---|---|
Was sermorelin ever FDA-approved? | Yes. A brand version, in 1990 and 1997.¹ |
Is it FDA-approved now? | No. The maker stopped selling it in 2008.¹ |
Was it pulled for safety? | No. In 2013, FDA found it was not withdrawn for reasons of safety or effectiveness.¹ |
What's prescribed today? | Compounded sermorelin, made by a licensed pharmacy for one patient, with a prescription.³ |
Does FDA review compounded sermorelin before it's sold? | No.² |
What was approved, and when
Two brand sermorelin injections had FDA approval.¹
1990: a low-dose injection, approved as a test. It checked whether the pituitary could release growth hormone. A diagnostic, not a treatment.
1997: a higher-dose injection, approved to treat children with growth failure from growth hormone deficiency with no known cause.
Both were injections. Neither approval covered the use most adults ask about today.
Why it stopped in 2008
In 2008, the maker told FDA it was discontinuing both products. FDA withdrew the approvals, effective June 18, 2009.¹
In 2012, a citizen petition asked FDA a direct question: was it pulled for safety or effectiveness? FDA checked its own files and reviewed reports of side effects after approval. Its answer, published in March 2013, was that neither product was withdrawn for reasons of safety or effectiveness.¹
You'll often read that the maker stopped "for business reasons." The FDA notice doesn't give the maker's reason. It only rules out safety and effectiveness. That's the part we can source, so that's the part we'll say.
The finding matters for compounding. Federal law bars pharmacies from compounding drugs FDA has listed as removed for being unsafe or ineffective.⁴
What compounded sermorelin is
Compounding means a pharmacy makes a medicine for one person. Under section 503A of federal law, a licensed pharmacist in a state-licensed pharmacy (or a licensed physician) can compound a drug for an identified patient, based on a valid prescription.³ ⁴
What FDA says about these drugs, in its own words: compounded drugs are not FDA-approved, and the agency does not review their safety, effectiveness or quality before they are marketed.²
Compounded sermorelin has no FDA approval.
What that means for you
No FDA review before it reaches you. The pharmacy's own quality matters more, so know which pharmacy fills it.
The research is small. Most sermorelin studies are short and include few people. See What is sermorelin? A simple guide for the two we lean on.
A clinician should read your history first. Some people shouldn't take it at all. The full list is in Sermorelin side effects: an honest list.
"FDA-approved sermorelin" is a red flag. If a seller says it about a compounded product, it's wrong.
How to check a pharmacy is licensed
Ask your provider for the pharmacy's name and the state it's in.
Look it up in that state's board of pharmacy license database. FDA's BeSafeRx page links to every state's lookup.⁵
Not listed? FDA says don't use that pharmacy.⁵
Once you find it, check that it requires a prescription, lists a US address and phone number, and has a licensed pharmacist to answer questions.⁵
Where Sommar fits
Sommar is async telehealth. Licensed US clinicians review your health history and prescribe compounded sermorelin only if it's appropriate. Injections are monthly at $175, or $119 for your first month with code FIRST40. FSA and HSA accepted. Cancel anytime. Pay nothing unless approved.
2-minute online quiz. A clinician reviews it. Prescribed only if appropriate.
More: sermorelin, prescribed online · for men · tablets vs injections
FAQ
Is compounded sermorelin legal? Under section 503A, a state-licensed pharmacy can compound a drug for one patient with a valid prescription.⁴ Compounding rules do change, so check the date at the top of this page.
Why was sermorelin discontinued? The maker stopped selling the brand in 2008. The FDA record doesn't give its reason. In 2013, FDA found it was not withdrawn for safety or effectiveness.¹
Are sermorelin tablets FDA-approved? No. Both approved brand products were injections.¹ Tablets sold today are compounded, like the injections.
Does the 2013 finding mean compounded sermorelin is safe? It means the brand wasn't pulled for safety. It says nothing about any compounded product, which FDA doesn't review before sale.² Side effects still happen. Read the honest list before you start.
Do I need a prescription? Yes. Compounding under 503A requires a valid prescription for you by name.⁴
Sources
U.S. Food and Drug Administration. Determination that sermorelin acetate injection, 0.5 mg and 1.0 mg base/vial, and sermorelin acetate injection, 0.05 mg base/amp, were not withdrawn from sale for reasons of safety or effectiveness. Docket No. FDA-2012-P-1071. Federal Register. March 4, 2013;78(42):14095-14096. https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/2013-04827.pdf (title shortened to drop the brand name; see disclaimer)
U.S. Food and Drug Administration. Understanding the Risks of Compounded Drugs. Content current as of June 22, 2026. https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs
U.S. Food and Drug Administration. Human Drug Compounding Laws. Content current as of December 17, 2024. https://www.fda.gov/drugs/human-drug-compounding/human-drug-compounding-laws
Federal Food, Drug, and Cosmetic Act, section 503A. 21 U.S.C. 353a, Pharmacy compounding. https://www.govinfo.gov/content/pkg/USCODE-2022-title21/html/USCODE-2022-title21-chap9-subchapV-partA-sec353a.htm
U.S. Food and Drug Administration. BeSafeRx: Locate a State-Licensed Online Pharmacy. Content current as of November 13, 2024. https://www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/locate-state-licensed-online-pharmacy
Prescription required. Compounded sermorelin is not FDA-approved. A licensed clinician decides if treatment is right for you. Individual results vary. Medical services provided by Wasef Health, PC. The brand product discussed above is Geref (sermorelin acetate) injection.
