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Sermorelin HSA/FSA Eligibility and Submission: Complete 2026 Guide

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At a glance

  • Current FDA status / Not FDA-approved; Geref discontinued 2008, approvals withdrawn 2009 [2]
  • What sermorelin is today / Compounded prescription, not an FDA-approved product [3]
  • FDA review of compounded drugs / FDA does not verify safety, effectiveness or quality before marketing [4]
  • IRS publication / Publication 502 lists drugs and medicines among medical-expense categories [1]
  • IRS list scope / Expense categories, not individual drug names [1]
  • Geref approved uses / Pediatric growth hormone deficiency and a pituitary diagnostic test only [2]
  • Withdrawal reason / FDA determined in 2013 it was not withdrawn for safety or effectiveness [2]

Does sermorelin qualify for HSA or FSA reimbursement?

Publication 502 is the IRS guide to medical and dental expenses. Its contents include Drugs, Medicines, Laboratory Fees and Physical Examination, and they are organized by expense category rather than by individual drug name [1]. Sermorelin does not appear as an entry in that list, so the publication gives no sermorelin-specific answer.

What the tax rules leave open, the product's regulatory status clarifies. Geref, the brand of sermorelin acetate, was approved in 1990 as a 0.05 mg/ampule diagnostic test and in 1997 as 0.5 mg and 1 mg vials for pediatric idiopathic growth hormone deficiency [2]. The maker discontinued Geref in 2008 and FDA withdrew the applications in 2009. In 2013 FDA determined it was not withdrawn for safety or effectiveness reasons [2]. Geref was not approved for adults, anti-aging, weight loss or athletic performance [2].

Sermorelin is a 29-amino-acid GHRH analogue, not growth hormone itself [5]. With Geref withdrawn, U.S. sermorelin products today are compounded, not FDA-approved [3]. FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed [4].

Frequently asked questions

Can I use HSA or FSA funds for sermorelin?
Publication 502 lists drugs and medicines among medical-expense categories but does not list sermorelin by name, so it does not answer the question for this product [1]. Sermorelin sold today is compounded, not FDA-approved [3].
Was sermorelin ever FDA-approved?
Yes, as Geref. It was approved in 1990 for a pituitary diagnostic test and in 1997 for pediatric idiopathic growth hormone deficiency [2]. The maker discontinued it in 2008 and FDA withdrew the approvals in 2009 [2].
Is today's sermorelin an FDA-approved product like Geref?
No. Geref's approvals were withdrawn in 2009 [2], and no sermorelin product is FDA-approved today [3].
What was Geref approved to treat?
Only pediatric idiopathic growth hormone deficiency with growth failure, plus a diagnostic test of the pituitary's ability to secrete growth hormone. It was not approved for adults, anti-aging, weight loss or athletic performance [2].
Does Publication 502 mention the prescriber visit and lab tests?
Its contents list physical examinations and laboratory fees among the medical-expense categories [1].
Does FDA review compounded sermorelin?
No. Compounded drugs are not FDA-approved, and FDA does not verify their safety, effectiveness or quality before they are marketed [4].

References

  1. Publication 502 (2025), Medical and Dental Expenses | Internal Revenue Service. Publication 502 (2025), Medical and Dental Expenses | Internal Revenue Service
  2. Federal Register :: Request Access. Federal Register :: Request Access
  3. Official web page. Official web page
  4. Compounding and the FDA: Questions and Answers | FDA. Compounding and the FDA: Questions and Answers | FDA
  5. 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 HSA/FSA Eligibility and Submission: Complete 2026 Guide