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Sermorelin International Purchase Legalities: What You Need to Know in 2026

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12 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • FDA-approved sermorelin sold today / none; both Geref approvals were withdrawn June 18, 2009 [1]
  • Geref's approved uses / pituitary growth hormone testing; pediatric growth hormone deficiency [1]
  • Compounded sermorelin / not FDA-approved; not reviewed for safety, effectiveness or quality [3]
  • Approved dose / none exists; no sermorelin product is currently FDA-approved [4][5]
  • FDA high-risk compounding list / sermorelin is not on it [6]
  • Sport / WADA prohibits it at all times on the 2026 and 2027 lists [7][8]

Is there an FDA-approved sermorelin anyone could import?

No. No approved sermorelin product remains on the US market [1].

Sermorelin acetate was approved twice, both times as Geref (EMD Serono): NDA 019863, a 0.05 mg/ampule product for evaluating the pituitary's ability to secrete growth hormone, approved December 28, 1990; and NDA 020443, 0.5 mg and 1 mg vials for idiopathic growth hormone deficiency in children with growth failure, approved September 26, 1997 [1].

The maker told FDA it was discontinuing the first on July 11, 2008 and the vials on December 2, 2008, and asked the agency to withdraw both applications; FDA withdrew the approvals effective June 18, 2009 [1]. In March 2013 FDA determined Geref had not been withdrawn for reasons of safety or effectiveness [1]. The approved uses were only the diagnostic test and pediatric growth hormone deficiency, never adults, anti-aging, weight loss or athletic performance [1].

What is sold today

In the US, sermorelin is dispensed as a compounded product. Compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before they are marketed [2][3]. No sermorelin product is currently FDA-approved, so there is no current approved dose. The pediatric study used 30 micrograms per kg once daily subcutaneously at bedtime and the older-men study used 0.5 mg or 1 mg twice daily for 14 days; those were study protocols, not recommended doses [4][5].

Where sermorelin sits with FDA

Sermorelin is not on FDA's page of bulk substances that may present significant safety risks when compounded (content dated April 22, 2026) [6]. On FDA's list of bulk substances nominated for outsourcing facilities it sits in category 1, under evaluation, marked as a component of FDA-approved drugs [9]. It appears in no category on FDA's list for state-licensed pharmacies and physicians and is not among the six peptides in HHS's October 2026 draft enforcement-discretion policy [10][11]. None of that is an approval [1][3].

FDA's compounding questions-and-answers page encourages consumers to research any online pharmacy or telehealth service first, including ones that market compounded drugs, and states that buying from unregulated, unlicensed sources can expose patients to poor-quality products [3].

Frequently asked questions

Is sermorelin on the WADA prohibited list?
Yes. The 2026 List names it in S2.2.4 as a growth hormone releasing factor, prohibited at all times, in and out of competition [7], and the 2027 List names it again [8].
Does FDA treat sermorelin as a risky bulk substance?
It is not on FDA's page of bulk substances that may present significant safety risks when compounded [6]. It sits in category 1, under evaluation, on the outsourcing-facility nominations list [9].
Is sermorelin the same as growth hormone?
No. It is a 29-amino-acid analogue of growth hormone-releasing hormone that prompts the pituitary to release the body's own growth hormone [12].

References

  1. Federal Register :: Request Access. Federal Register :: Request Access
  2. Official web page. Official web page
  3. Compounding and the FDA: Questions and Answers | FDA. Compounding and the FDA: Questions and Answers | FDA
  4. Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, et al. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group. J Clin Endocrinol Metab. 1996;81(3):1189-96. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group
  5. Corpas E, Harman SM, Piñeyro MA, Roberson R, Blackman MR. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. J Clin Endocrinol Metab. 1992;75(2):530-5. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men
  6. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  7. World Anti-Doping Agency. World Anti-Doping Agency
  8. World Anti-Doping Agency. World Anti-Doping Agency
  9. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  10. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  11. Official web page. Official web page
  12. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-57. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency
Evidence overview for Sermorelin International Purchase Legalities: What You Need to Know in 2026