Longevity

Is Sermorelin FDA Approved? The Full Regulatory Record

Sermorelin held two FDA approvals as GEREF. Both were discontinued, and FDA stated in 2013 it was not for safety or effectiveness reasons.

By Juan Montes Updated October 3, 2026 · 5 min read

Short answer: no, not currently. But the full answer is more interesting than that, and more favourable to sermorelin than most pages on either side of the argument suggest. Sermorelin held two FDA approvals. They were discontinued. And FDA has stated on the record that the withdrawal was not for reasons of safety or effectiveness.

That last point is a matter of public record in the Federal Register, and almost nobody publishes it.

Sermorelin held two FDA approvals. FDA stated in 2013 that their withdrawal was not for safety or effectiveness reasons.

Important
This article is general education, not medical advice, and nothing in it recommends or endorses a treatment for you. Compounded medications discussed here are not FDA approved. Only a clinician licensed in your state can decide whether any treatment is appropriate, and that decision follows a review of your history and any testing they consider necessary. Do not start, stop or change any medication based on something you read online. If you are having a medical emergency, call 911.

The approvals that existed

Sermorelin acetate was marketed as GEREF, sponsored by EMD Serono, under two separate applications:

Application	Approved	Product
NDA 019863	28 December 1990	GEREF (sermorelin acetate) injection
NDA 020443	26 September 1997	GEREF DIAGNOSTIC (sermorelin acetate) injection

Both were genuine FDA approvals, reviewed for safety and effectiveness in the ordinary way. Neither product is marketed today.

Why they were discontinued, in FDA’s words

This is the part that matters. When a drug product is withdrawn from sale, FDA publishes a determination of whether the withdrawal was for safety or effectiveness reasons. That determination governs whether generics can be approved, so it is made deliberately and it is public.

In a Federal Register notice dated 4 March 2013, FDA determined that the GEREF products “were not withdrawn from sale for reasons of safety or effectiveness.”

In plain terms: the products left the market for commercial reasons. FDA did not pull them, did not find a safety signal that forced them off, and did not conclude they failed to work. That is a materially different history from a drug withdrawn after adverse findings, and it is a fair thing to say about sermorelin.

What you still cannot say

None of the above makes present-day sermorelin an FDA-approved drug, and the distinction is not a technicality.

“Sermorelin is FDA approved” is inaccurate in the present tense. No approved sermorelin product is on the market.
Compounded sermorelin is an unapproved drug. It is prepared by a licensed pharmacy against an individual prescription. FDA has not reviewed that preparation for safety or effectiveness, and it carries no approved label.
“FDA Category 1 approved” does not exist. Sermorelin appears in Category 1 of the 503B nominations list, updated 21 March 2025. Category 1 describes substances nominated for use by outsourcing facilities that FDA has placed in an interim enforcement discretion posture while it completes its evaluation. It is neither an approval nor an endorsement, and anyone using the phrase is describing something that does not exist.
A past approval is not a current one. The 1990 and 1997 approvals covered specific products made to a specific specification by a specific sponsor. They say nothing about the quality of any compounded preparation sold today.

Where sermorelin sits on FDA’s compounding lists

List	Status	As of
503A bulk drug substances, Category 1, 2 or 3	Does not appear	14 May 2026
Category 2, substances that raise significant safety risks	No finding	14 May 2026
503B nominations	Category 1	21 March 2025
FDA risk alerts naming sermorelin	None	Alerts page updated 30 June 2026

For context on what a Category 2 finding looks like when one does exist, FDA placed ipamorelin acetate in Category 2 on 29 September 2023, citing immunogenicity risk, unnatural amino acids, and serious adverse events including death when administered intravenously. Sermorelin carries nothing comparable. That is an absence of a negative finding rather than a positive endorsement, but the difference between the two peptides on the record is real.

What compounded actually means

Compounding is legal, long established, and widespread. It is how patients get medications that are not commercially available in the form or strength they need. It is not a loophole and it is not inherently suspect.

What it is not is FDA approval. A compounded preparation has not been through premarket review, has no FDA-approved label, and its consistency depends on the pharmacy that made it. Two sermorelin preparations from two pharmacies are not necessarily the same thing. That is the honest trade, and a provider prescribing it should be able to tell you which pharmacy is filling it.

Frequently asked

Was sermorelin banned?

No. It was never banned or withdrawn by FDA. The approved products were discontinued commercially, and FDA stated in 2013 that this was not for safety or effectiveness reasons.

Is sermorelin legal?

Compounded sermorelin can be prescribed by a licensed clinician and prepared by a licensed pharmacy. It is an unapproved drug, which is a different thing from an illegal one.

If it worked, why did they stop making it?

FDA’s determination speaks to whether the withdrawal was for safety or effectiveness, not to the commercial reasoning behind it. The public record establishes what it was not; it does not establish the company’s internal reasons.

Does a past approval mean it is safe?

It means the products approved in 1990 and 1997 met FDA’s standard at the time, and that FDA did not later find a safety reason to remove them. It does not extend to compounded preparations sold today, which FDA has not reviewed.

Considering sermorelin therapy?

PrescribedRX offers sermorelin injections by prescription. Answer a few questions about your health history and a clinician licensed in your state reviews whether treatment is appropriate for you. Compounded sermorelin is not FDA approved, and a clinician may decide it is not right for you.

See sermorelin options

References

U.S. Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection and GEREF DIAGNOSTIC (Sermorelin Acetate) Injection Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register, 4 March 2013.
U.S. Food and Drug Administration. Drugs@FDA records for GEREF, NDA 019863 (approved 28 December 1990) and NDA 020443 (approved 26 September 1997).
U.S. Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act. Updated 14 May 2026.
U.S. Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Updated 21 March 2025.
U.S. Food and Drug Administration. Bulk Drug Substances That Raise Significant Safety Risks (Category 2). Ipamorelin acetate entry dated 29 September 2023.

Longevity plans from PrescribedRX

PrescribedRX prescribes longevity treatments through clinicians licensed in your state:

Glutathione Injection. Administered by injection after a provider consultation.
Glutathione Nasal Spray. A nasal alternative.
NAD+ Injections. On a schedule set by your provider.
NAD+ Nasal Spray. A nasal alternative.
Sermorelin Injections. By prescription after consultation.

Every plan and its current price is on the plans page and the pricing page.

These are compounded preparations. Compounded drugs are not reviewed or approved by the FDA for safety or effectiveness, and treatment outcomes are not guaranteed.

This article is for general information. It is not medical advice and it is not a recommendation for any particular treatment. Whether a treatment is appropriate for you is a decision for a licensed clinician who has reviewed your health history and current medications.

About the author

Juan Montes

Juan Montes writes and reviews PrescribedRX's clinical content, covering testosterone replacement therapy, men's sexual health, weight management and hair loss. He trained as a Professional Nurse at the Colombian Red Cross in Cali, Colombia, and has worked in healthcare since 2011, roughly six of those years in direct emergency and critical care nursing. He served as Head Nurse in Emergency…