Using HGH for anti-aging is not an approved use, and federal law makes it a crime, punishable by up to 5 years in prison, to distribute HGH for any use other than an FDA-authorized one ordered by a physician [4]. Sermorelin has had no FDA-approved product since 2009 and is sold compounded, with a legal basis FDA has not confirmed [3] [10].
Sermorelin is a GHRH analog that signals the pituitary to make growth hormone [2]; HGH, or somatropin, is lab-made human growth hormone sold as FDA-approved brands such as Genotropin [1].
At a glance
HGH is growth hormone itself. Sermorelin signals the body to make its own [1] [2].
Side by sideDistributing HGH for anti-aging or other unapproved uses can bring up to 5 years in prison, 10 if a minor is involved [4].
HGH for anti-aging and the lawA review of 18 study groups in healthy older adults found small body composition changes and more side effects on HGH [6].
What the research has shown
Quick answer
HGH is the hormone; sermorelin is a signal to make it. Somatropin brands such as Genotropin are FDA-approved for children with growth failure from growth hormone deficiency, Prader-Willi syndrome, Turner syndrome, small size for gestational age and idiopathic short stature, and for adults with growth hormone deficiency [1]. WADA lists sermorelin as a growth hormone releasing hormone (GHRH) analog [2]. Sermorelin's only approved brand, Geref, was for children with idiopathic growth hormone deficiency, and FDA withdrew its approval effective June 18, 2009 at the maker's request [3]. Neither is approved for aging, energy or body composition in healthy adults.

Side by side
| Sermorelin | HGH (somatropin) | |
|---|---|---|
| What it is | GHRH analog that prompts the pituitary to release growth hormone [2] | Lab-made human growth hormone [1] |
| FDA status | No approved product since June 18, 2009 [3] | FDA-approved brands, such as Genotropin [1] |
| Approved uses | Former brand Geref: idiopathic growth hormone deficiency in children with growth failure [3] | Growth failure from growth hormone deficiency and other listed conditions in children; growth hormone deficiency in adults [1] |
| Anti-aging use | Not an approved use; no FDA label exists [3] | Not an approved use; distribution for it is a federal crime [4] |
| Compounding | Sold compounded; legal basis not confirmed [9] [10] | Not eligible: somatropin products became biologics on March 23, 2020 [7] [8] |
| Evidence in healthy older adults | Studies of 10 to 19 people, 2 to 16 weeks [11] [12] | 18 study groups; about 2 kg less fat and 2 kg more lean mass, more side effects [6] |
| Key risks | No current label; transient high blood fats in one small study [12] | Label warnings include higher death rates in acute critical illness, tumor risk, diabetes and fluid retention [1] |
| Sports (WADA) | Banned at all times, class S2 [2] | Banned at all times, class S2 [2] |
| How to get it legally | Prescription for a compounded product; status not confirmed [10] | Prescription for an approved use, filled by a pharmacy [1] [4] |
| Price | $119 to $179 a month compounded at two sellers [14] [15] | Genotropin 5 mg, 3 cartridges: $935.04 with GoodRx, $3,556.60 retail [13] |
HGH for anti-aging and the law
HGH is one of the few drugs with its own federal distribution crime. Under 21 U.S.C. 333(e), "whoever knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 355 of this title and pursuant to the order of a physician" faces up to 5 years in prison [4]. If the offense involves someone under 18, the maximum is 10 years [4]. The law defines human growth hormone as somatrem, somatropin or an analog of either, and authorizes the Drug Enforcement Administration to investigate [5].
In plain terms: a prescription for an approved use, such as adult growth hormone deficiency, is legal. Supplying HGH for anti-aging, athletic performance or body composition in healthy people is not an approved use, so the law's exception does not cover it [1] [4]. Compounding is not a way around this. Somatropin products were among the drugs deemed biologics on March 23, 2020 [7], and FDA says those biologics are not eligible for the 503A or 503B compounding exemptions [8].
Sermorelin's legal status
Sermorelin is not on any of FDA's 503A category lists [9]. FDA determined in 2013 that Geref was "not withdrawn for reasons of safety or effectiveness" [3]. Under 503A, a pharmacy may compound with a bulk substance that is a component of an FDA-approved drug, but FDA has not said whether a drug whose approval was withdrawn counts [10]. Clinics and telehealth companies sell compounded sermorelin by prescription. Compounded drugs are not FDA-approved, and compounded sermorelin is not a generic of Geref. More on our sermorelin page.
Legal status of Sermorelin
Not confirmedSermorelin was the active ingredient in Geref, an FDA-approved drug whose approval FDA withdrew in 2009 at the maker's request [3]. We could not find an FDA statement on whether pharmacies may compound it, so its status is not confirmed [9].
- FDA status
- Sermorelin is not on any of FDA's 503A category lists [9]. It was the active ingredient in Geref. The maker stopped selling Geref, and FDA withdrew its approval at the maker's request, effective June 18, 2009 [3]. In 2013, FDA determined that Geref was not withdrawn from sale for reasons of safety or effectiveness [3]. Under 503A, a pharmacy may compound with a bulk substance that is a component of an FDA-approved drug when no USP or NF monograph exists [10]. FDA's 503A page does not say whether a drug whose approval was withdrawn counts [10]. We found no FDA statement applying this rule to sermorelin, so we list its status as not confirmed.
- Advisory committee
- We found no advisory committee review of sermorelin.
- FDA-approved products
- None. Geref was FDA-approved, but FDA withdrew its approval in 2009 after the maker stopped selling it [3].
- Sports (WADA)
- Prohibited under class S2 as a growth hormone releasing hormone analog. Sermorelin is named [2].
- What happens next
- FDA would need to state whether sermorelin qualifies as a component of an approved drug, or act on it another way. We found no pending FDA action.
Checked against FDA sources on . We update this box when FDA acts. Report a change: [email protected].
What the research has shown
HGH in healthy older adults
A 2007 systematic review in the Annals of Internal Medicine pooled randomized trials covering 18 study groups, with 220 people on growth hormone completing them; average age was 69 and average treatment 27 weeks [6]. Fat mass fell an average of 2.1 kg and lean body mass rose 2.1 kg, with no change in weight [6]. People on growth hormone were more likely to have soft tissue swelling, joint pain, carpal tunnel syndrome and breast enlargement in men, and somewhat more likely to develop diabetes or impaired fasting glucose [6]. The authors concluded growth hormone "cannot be recommended" as an anti-aging therapy [6].
Sermorelin in older adults
The studies are smaller. In a 1992 study, 10 healthy older men (average age 68) took GHRH-(1-29) for 14 days; the higher dose raised growth hormone and IGF-1 to levels that no longer differed from young men's, and body composition was not measured [11]. A 1997 study gave a modified form, [Nle27]GHRH-(1-29), to 19 adults aged 55 to 71 for 16 weeks: lean body mass rose in men only, skin thickness rose in both sexes, and transient high blood fats were reported [12]. Neither tested long-term outcomes, and neither used today's compounded products. Human evidence for sermorelin as an anti-aging treatment is thin.
Known risks
- HGH label warnings: higher death rates in people with acute critical illness given high doses, second tumors in childhood cancer survivors treated with head radiation, reduced insulin sensitivity and diabetes, raised pressure in the skull, severe allergic reactions, fluid retention and pancreatitis [1]. It should not be used with active cancer [1].
- HGH side effects in adults: in the Genotropin label's 6-month placebo-controlled phase, swelling in the limbs affected 17.5% vs 5.1% on placebo and joint pain 17.3% vs 4.2% [1].
- Sermorelin: no current FDA label, so there are no labeled warnings or side effect rates; one small 1997 study of a modified form reported transient high blood fats [12].
- Both: banned at all times for tested athletes under WADA class S2 [2].
When to get help
Severe headache with vision changes, severe stomach pain that will not go away, or hives, swelling of the face, lips or throat or trouble breathing after an injection need prompt care [1]. Call 911 in an emergency.
Price
On GoodRx, 3 cartridges of Genotropin 5 mg listed at $3,556.60 retail and $935.04 with its coupon, and 3 cartridges of 12 mg at $6,191.61 retail and $2,244.12 with the coupon, checked Oct 25, 2026 [13]. Insurance usually needs a diagnosis that fits the label. Compounded sermorelin was $119 to $159 a month at PlexusDx [14] and $149 to $179 a month at Rx.com [15] on the same date; those are prices for a product whose legal basis FDA has not confirmed. More: legal peptide price tracker.
Related drugs
Tesamorelin (Egrifta WR) is an FDA-approved GHRH analog, but only to reduce excess abdominal fat in adults with HIV and lipodystrophy, and its label says it is not for weight loss [16]. See tesamorelin. Growth hormone secretagogues sold online, such as ipamorelin, cannot be legally compounded; see ipamorelin vs sermorelin and CJC-1295 and ipamorelin. If low energy or low testosterone is the concern, the approved options are on testosterone therapy. Other injectables: wellness injections.
How we check
HGH facts come from the current FDA label on DailyMed and the US Code. Sermorelin status comes from FDA's Federal Register notice and 503A pages, through our peptide status file. Study results come from published abstracts. Prices come from GoodRx and the sellers' pages on Oct 25, 2026; listing a price is not an endorsement. Our method: editorial standards.
Questions people ask
Is sermorelin the same as HGH?
Is it legal to use HGH for anti-aging?
Is sermorelin better than HGH?
How much does HGH cost compared with sermorelin?
Can a pharmacy compound HGH?
Medical review: pending. A licensed clinician has not yet reviewed this page.
Sources
16 cited
- Genotropin (somatropin) prescribing information. DailyMed, NLM/NIH (Pfizer), Jul 2026.
- 2026 Prohibited List. World Anti-Doping Agency (copy hosted by Asia Rugby), Sep 2025.
- Determination that Geref (sermorelin acetate) products were not withdrawn from sale for reasons of safety or effectiveness. FDA (Federal Register), Mar 4, 2013.
- 21 U.S.C. 333: Penalties (subsection (e), prohibited distribution of human growth hormone). US Government Publishing Office (United States Code), 2023.
- 21 U.S. Code 333: Penalties. Legal Information Institute, Cornell Law School, Oct 25, 2026.
- Systematic review: the safety and efficacy of growth hormone in the healthy elderly (Liu et al., Ann Intern Med 2007;146(2):104-115). PubMed, Jan 16, 2007.
- List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020. FDA, Apr 2, 2020.
- Notice to compounders: changes that affect compounding on March 23, 2020. FDA, Mar 5, 2020.
- Bulk drug substances nominated for use in compounding under section 503A (categories document). FDA, May 14, 2026.
- Bulk drug substances used in compounding under section 503A of the FD&C Act. FDA, May 14, 2026.
- Growth hormone-releasing hormone-(1-29) twice daily reverses the decreased GH and IGF-I levels in old men (Corpas et al., J Clin Endocrinol Metab 1992;75(2):530-535). PubMed, Aug 1992.
- Endocrine and metabolic effects of long-term administration of [Nle27]GHRH-(1-29)-NH2 in age-advanced men and women (Khorram et al., J Clin Endocrinol Metab 1997;82(5):1472-1479). PubMed, May 1997.
- Genotropin prices. GoodRx, Oct 25, 2026.
- Sermorelin. PlexusDx, Oct 25, 2026.
- Sermorelin. Rx.com (Rx Platform LLC), Oct 25, 2026.
- Egrifta WR (tesamorelin) prescribing information. FDA, Mar 2025.
This page is general information, not medical advice. Talk with a licensed clinician about your own care.