The short answer. Sermorelin was FDA-approved as Geref, and FDA withdrew that approval in 2009 after the manufacturer stopped selling it. FDA later found it was not withdrawn for safety or effectiveness. As of September 25, 2026, it is the one growth hormone axis peptide on this tracker with a defensible compounding position, from a licensed pharmacy with pharmaceutical-grade ingredient.
| FDA approved | Formerly. Geref (NDA 19-863, 1990; NDA 20-443, 1997). Approval withdrawn Jun 18, 2009. |
|---|---|
| Why it was withdrawn | The manufacturer discontinued it. FDA determined in 2013 it was not withdrawn for safety or effectiveness (78 FR 14095). |
| 503A pharmacy | Compounded as a component of an approved drug. See the caveat below. |
| 503B outsourcing facility | Sermorelin acetate is in 503B Category 1, marked by FDA as a component of an approved drug. |
| Latest FDA action | Warning letter to Xcel Research over “research” sermorelin, Dec 10, 2024. |
| MDside position | Patient-specific, from a licensed 503A pharmacy, pharmaceutical-grade ingredient with documentation. Never research-labeled product. |
| Last verified | 2026-09-25 |
Why the 2013 determination matters
When an approved drug leaves the market, FDA can decide whether it left for safety or effectiveness reasons. A drug withdrawn for those reasons may not be compounded. In 2013, answering a citizen petition, FDA found that neither Geref product was withdrawn for safety or effectiveness. That finding keeps sermorelin eligible for compounding.
The copy rule does not bite, because nothing is on the market
FDA’s essentially-a-copy guidance applies to copies of commercially available drugs, and it treats a drug that has been discontinued and is no longer marketed as not commercially available. No sermorelin product is marketed in the US, so the four-a-month limit that constrains semaglutide does not apply here.
The caveat, stated plainly
Pharmacies compound sermorelin under 503A on the basis that it is a component of an FDA-approved drug. FDA describes sermorelin acetate that way in its 503B categories list. As of September 25, 2026, FDA has not published a 503A-specific statement on the point, and no court has addressed it. We treat the position as sound because FDA’s own list applies it, and we note the gap rather than paper over it.
Where sermorelin goes wrong
The failures are in sourcing and sterility. FDA’s December 2024 warning letter to Xcel Research treated research-labeled sermorelin as an unapproved new drug. Earlier letters to Innoveix (2022) and Talon Compounding (2017) involved sterility and aseptic practice failures. A lawful ingredient compounded badly is still a problem for the clinic that administers it.
What this means for you
If sermorelin is on your menu, confirm three things in writing: the pharmacy’s license and 503A status, the ingredient source and its certificate of analysis, and that each prescription names a patient. Drop any supplier selling it as a research chemical. Our hormone therapy and peptide programs are sourced this way.
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Frequently asked questions
Is sermorelin FDA-approved?
Not currently. It was approved as Geref in 1990 and 1997, and FDA withdrew the approvals in 2009 after the manufacturer discontinued the product. In 2013 FDA determined the withdrawal was not for safety or effectiveness, which keeps sermorelin eligible for compounding.
Can a pharmacy compound sermorelin?
Yes, in our reading, as a component of an approved drug, for a named patient, from pharmaceutical-grade ingredient. FDA lists sermorelin acetate that way for outsourcing facilities. As of September 25, 2026 FDA has not addressed the 503A side specifically.
Does the four-prescriptions-a-month limit apply to sermorelin?
No. That limit belongs to the essentially-a-copy rules, which apply only to copies of commercially available drugs. FDA treats a discontinued drug that is no longer marketed as not commercially available, and no sermorelin product is marketed in the US.
Primary sources. Last verified September 25, 2026. Corrections are welcome: contact us.
- 78 FR 14095 (Mar 4, 2013), determination that Geref was not withdrawn for reasons of safety or effectiveness
- FDA, 503B bulk drug substance categories (updated Mar 21, 2025)
- FDA, 503A bulk drug substance categories (updated May 14, 2026)
- FDA guidance, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (Jan 2018)
- FDA warning letter, Xcel Research (Dec 10, 2024)
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.