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Sermorelin Compounding Pharmacy FDA and State Board Enforcement History

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8 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • Approval history / Geref, two NDAs, approved in 1990 and 1997 [1]
  • Current status / No sermorelin product is FDA-approved [1]
  • Withdrawal / Maker discontinued in 2008; FDA withdrew approvals in 2009 [1]
  • Withdrawal reason / FDA later said not for safety or effectiveness [1]
  • Safety-risk bulk list / Sermorelin not listed [4]
  • Outsourcing-facility list / Category 1, under evaluation [2]
  • State-licensed pharmacy list / Sermorelin not listed [3]
  • HHS October 2026 policy / Not among the six peptides [5]

What the FDA record shows

Geref was approved under two NDAs. NDA 019863 covered the 0.05 mg product for a pituitary growth hormone diagnostic test, originally approved December 28, 1990 [1]. NDA 020443 covered the 0.5 mg and 1 mg vials for treating idiopathic growth hormone deficiency in children with growth failure, originally approved September 26, 1997 [1]. Those were the only approved uses. Geref was not approved for adults, anti-aging, weight loss or athletic performance [1].

The manufacturer discontinued Geref in 2008, notified FDA on July 11, 2008 for the 0.05 mg product and December 2, 2008 for the vials, and asked FDA to withdraw the applications [1]. FDA withdrew both approvals effective June 18, 2009 [1]. In March 2013 FDA determined that Geref was not withdrawn from sale for reasons of safety or effectiveness [1]. Drugs@FDA lists both products as discontinued with that determination, and the only sermorelin applications there are those two Geref NDAs [1][6].

Where sermorelin sits on FDA's lists

Sermorelin does not appear on FDA's page of bulk substances that may present significant safety risks, content dated April 22, 2026, and FDA has not published a safety-risk warning about sermorelin as a bulk substance on that page [4]. That is a list status, not a finding that compounded sermorelin is safe.

On FDA's list of nominated bulk substances for outsourcing facilities, updated March 21, 2025, sermorelin acetate is category 1, under evaluation, and is marked as a component of FDA-approved drugs [2]. It does not appear in any category on FDA's list for state-licensed pharmacies and physicians, updated May 14, 2026 [3]. It is also not one of the six peptides in HHS's October 2026 draft enforcement-discretion policy [5].

Is compounded sermorelin FDA-approved?

No. With Geref withdrawn, sermorelin products in the US today are compounded, not FDA-approved. FDA does not review their safety, effectiveness or quality before they are marketed [7]. Sermorelin is a 29-amino-acid analogue of human growth hormone-releasing hormone, not growth hormone itself [8].

Frequently asked questions

What federal actions name sermorelin?
The federal record is the withdrawal of the two Geref NDAs. Geref was discontinued in 2008, and FDA withdrew the approvals effective June 18, 2009 [1].
Was Geref withdrawn for safety or effectiveness?
No. The maker discontinued Geref in 2008 and asked FDA to withdraw the applications. In March 2013 FDA determined that Geref was not withdrawn from sale for reasons of safety or effectiveness [1].
Is compounded sermorelin FDA-approved?
No. With Geref withdrawn, sermorelin products in the US today are compounded, not FDA-approved. FDA does not review their safety, effectiveness or quality before they are marketed [7].
What is sermorelin's outsourcing-facility list status?
On FDA's list of nominated bulk substances for outsourcing facilities, updated March 21, 2025, sermorelin acetate is category 1, under evaluation, and marked as a component of FDA-approved drugs [2].

References

  1. Federal Register :: Request Access. Federal Register :: Request Access
  2. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  3. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  4. 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
  5. Official web page. Official web page
  6. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  7. Official web page. Official web page
  8. 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 Compounding Pharmacy FDA and State Board Enforcement History