Sermorelin held FDA approval as Geref until the manufacturer discontinued it. FDA withdrew the applications effective June 18, 2009, and later determined explicitly that the products were not withdrawn for reasons of safety or effectiveness. It was a commercial exit, not a safety action.
Sermorelin is not FDA-approved. Every prescription dispensed in the United States today is a compounded preparation, which means FDA does not verify the safety, effectiveness or quality of the drug before it is marketed [1]. That is a real distinction worth understanding, and it is also frequently misrepresented in both directions: by marketers who imply approval exists, and by critics who imply the withdrawal was a safety judgment. Neither is accurate.
- Sermorelin has no current FDA approval. All US supply is compounded [1]
- It previously held approval as Geref. FDA withdrew the applications effective June 18, 2009 [2]
- FDA determined the withdrawal was not for reasons of safety or effectiveness [2]
- Compounded drugs are not FDA-approved and do not undergo premarket review [1]
- Sermorelin is a peptide, not an anabolic steroid, and does not appear on DEA's controlled substances list [3][4]
What Happened to the FDA Approval
Sermorelin acetate was marketed as Geref and approved for diagnostic use and for treating growth hormone deficiency in children. The manufacturer discontinued production, and FDA withdrew approval of NDA 19-863 and NDA 20-443 effective June 18, 2009 [2].
The agency revisited the question in 2013 and published a formal determination that the products were not withdrawn for reasons of safety or effectiveness [2]. That determination exists so generic applications could be approved if anyone filed one. The commercial context was that recombinant human growth hormone had taken over the pediatric growth hormone deficiency market, leaving Geref without enough volume to justify manufacturing.
A withdrawal for safety would appear in the same Federal Register process and would say so. This one says the opposite. Anyone citing the withdrawal as evidence that sermorelin was found dangerous is contradicting the document they are pointing at.
What "Compounded" Actually Means
Since there is no approved sermorelin product, prescriptions are filled by compounding pharmacies. FDA states the position plainly: compounded drugs are not FDA-approved, which means FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed [1].
Two regulatory pathways exist, and the difference between them is the single most useful thing to understand when comparing providers.
| Section 503A pharmacy | Section 503B outsourcing facility | |
|---|---|---|
| FDA-approved product? | No [1] | No [1] |
| Subject to cGMP requirements? | [No](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers) [1] | [Yes](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers) [1] |
| Primary oversight | [State boards of pharmacy](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers) [1] | [FDA, inspected on a risk-based schedule](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers) [1] |
| Compounds for | Identified individual patients | Larger batches, with or without patient-specific prescriptions |
| Sterility standard applied | USP 797 [5] | USP 797 plus cGMP [1][5] |
Neither pathway produces an FDA-approved drug. A 503B facility is held to a materially higher manufacturing standard, which is why provider sourcing is worth asking about directly rather than accepting "licensed pharmacy" as an answer.
A Regulatory Ambiguity Worth Knowing About
Compounding from a bulk drug substance generally requires that the substance have a USP or NF monograph, be a component of a currently FDA-approved product, or appear on FDA's 503A bulk substances list. Sermorelin does not appear on FDA's 503A or 503B bulk substances lists [6], and Geref's approval was withdrawn in 2009, so it is no longer a component of a currently approved product.
It is also not on FDA's category of bulk substances identified as presenting significant safety risks [6]. The honest summary is that sermorelin occupies an ambiguous position rather than a clearly settled one, and this is a live area: FDA has been reviewing several peptides used in compounding. Patients should treat regulatory status as something that can change during a 6-month protocol.
Is Sermorelin a Steroid or a Controlled Substance?
No on both counts, and the two questions get conflated often enough to be worth separating.
Sermorelin is a peptide. It is a 29-amino-acid analog of human GHRH and the shortest synthetic peptide retaining full biological activity [3]. It works by stimulating pituitary GHRH receptors. Anabolic-androgenic steroids are a different chemical class acting on androgen receptors, with a different mechanism and a different risk profile.
On scheduling: anabolic steroids are listed as Schedule III controlled substances. Sermorelin does not appear on DEA's published list of controlled substances [4]. It requires a prescription, but it is not a scheduled drug.
Not being DEA-scheduled does not mean permitted in sport. Sermorelin is named explicitly on the WADA Prohibited List under growth hormone releasing factors and is banned at all times, in and out of competition.
What the Safety Data Shows
The controlled adult data is limited but reassuring within its scope. In the 16-week trial of [[Nle27]GHRH(1-29)NH2, a norleucine-substituted analog of the fragment sermorelin is built on, given at 10 mcg/kg nightly to adults aged 55 to 71](https://pubmed.ncbi.nlm.nih.gov/9141536/) [7], the only adverse effect reported was a transient hyperlipidemia that resolved by the end of the study.
That is a narrow evidence base: one trial, 16 weeks, older adults, a closely related but not identical molecule. It supports the claim that short-term tolerability was good in that population. It does not establish long-term safety, and no long-term controlled data in adults exists.
What to Ask a Provider
Since FDA approval is not available as a quality signal, the questions that remain useful are about the pharmacy and the clinical process.
- Is the compounding pharmacy registered as a 503A pharmacy or a 503B outsourcing facility?
- Can you provide a Certificate of Analysis for the lot I receive?
- What sterility and potency testing is performed, and to what standard?
- Is a baseline IGF-1 required before prescribing, and is a 90-day retest included?
- Which physician is prescribing, and are they licensed in my state?
A provider selling compounded sermorelin should state plainly that the product is not FDA-approved. A platform that avoids saying so, or implies approval through phrasing like "FDA-registered pharmacy," is managing your impression rather than informing you. FDA registration of a facility is not approval of a drug.
Frequently Asked Questions
Is sermorelin FDA approved?
No. Sermorelin has no current FDA approval, and all US supply is compounded. FDA states that compounded drugs are not FDA-approved and that it does not verify their safety, effectiveness, or quality before marketing [1]. Sermorelin previously held approval as Geref, but FDA withdrew those applications effective June 18, 2009 after the manufacturer discontinued the product [2].
Why was sermorelin taken off the market?
For commercial reasons. The manufacturer discontinued it because recombinant human growth hormone had taken over the pediatric growth hormone deficiency market. FDA formally determined in 2013 that the Geref products were not withdrawn from sale for reasons of safety or effectiveness [2]. That determination exists specifically so generic applications could be approved if a company filed one.
Is compounded sermorelin legal?
Compounded medications are dispensed lawfully under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act when the applicable conditions are met, and sermorelin is prescribed this way throughout the US. Worth knowing: sermorelin does not appear on FDA's 503A or 503B bulk substances lists [6], and it is no longer a component of a currently approved product, so its status is less settled than that of many compounded drugs. It is also not on FDA's list of bulk substances presenting significant safety risks [6].
Is sermorelin a steroid?
No. Sermorelin is a peptide, specifically a 29-amino-acid analog of human growth hormone-releasing hormone [3]. It acts on GHRH receptors in the pituitary to stimulate the body's own growth hormone release. Anabolic-androgenic steroids are an unrelated chemical class that act on androgen receptors. The mechanisms, effects, and risk profiles are different.
Is sermorelin a controlled substance?
It does not appear on DEA's published list of controlled substances [4]. Anabolic steroids, by contrast, are Schedule III. Sermorelin still requires a prescription from a licensed physician, but it is not scheduled. Separately, it is prohibited in tested sport at all times under the WADA Prohibited List, which is an anti-doping rule rather than a controlled-substance classification.
Is sermorelin safe if it is not FDA approved?
Lack of approval is a statement about regulatory review, not a finding of harm. The available controlled data is limited: a 16-week trial of a close GHRH(1-29) analog in adults aged 55 to 71 reported transient hyperlipidemia as the only adverse effect, and it resolved [7]. No long-term controlled adult safety data exists. The practical risk with compounded products is product quality, which is why 503A versus 503B sourcing and Certificate of Analysis availability are the questions that matter.
References
- Compounding and the FDA: questions and answers FDA.gov, Human Drug Compounding, 2025. Content current as of 09/16/2025. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
- Determination that GEREF (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness Federal Register, 78 FR 14095, 2013. FR Doc. 2013-04827. https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm
- Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency BioDrugs, 1999. PMID: 18031173. https://pubmed.ncbi.nlm.nih.gov/18031173/
- Lists of scheduling actions, controlled substances, and regulated chemicals U.S. Department of Justice, 2026. DEA Orange Book. https://www.deadiversion.usdoj.gov/schedules/orangebook/orangebook.pdf
- General Chapter <797> Pharmaceutical Compounding: Sterile Preparations USP, 2023. Official November 1, 2023. https://www.usp.org/compounding/general-chapter-797
- Bulk drug substances used in compounding under section 503A of the FD&C Act FDA.gov, 2025. FDA Human Drug Compounding. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
- Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in age-advanced men and women Journal of Clinical Endocrinology & Metabolism, 1997. PMID: 9141536. https://pubmed.ncbi.nlm.nih.gov/9141536/
