Sermorelin FDA status
Is sermorelin FDA-approved?
No sermorelin product is currently FDA-approved and on the US market. FDA approved two sermorelin acetate products under the brand name Geref: a diagnostic injection in 1990 and a treatment for certain children with growth hormone deficiency in 1997. The manufacturer discontinued both in 2008, and FDA withdrew the approvals in 2009 at the company's request. In 2013 FDA determined that Geref had not been withdrawn for reasons of safety or effectiveness. The sermorelin sold by online clinics today is compounded, and FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.
Dates each regulatory step from the Federal Register and FDA's own product database, and keeps Geref's history separate from the status of the compounded sermorelin sold online today. It is a bounded source review, not a systematic review or individual medical advice.
Approved today
No FDA-approved sermorelin product is marketed
Historical approvals
Geref, 1990 (diagnostic) and 1997 (pediatric treatment)
Online products
Compounded and not FDA-approved
Swipe the evidence table sideways to read every column.
| Date | Product | What happened | Where it is recorded |
|---|---|---|---|
| December 28, 1990 | Geref 0.05 mg (NDA 19-863) | Approved for evaluating the pituitary gland's ability to secrete growth hormone | Federal Register, March 4, 2013 |
| September 26, 1997 | Geref 0.5 mg and 1.0 mg vials (NDA 20-443) | Approved for idiopathic growth hormone deficiency in children with growth failure | Federal Register, March 4, 2013 |
| July and December 2008 | Both Geref products | EMD Serono told FDA it was discontinuing them and asked for both approvals to be withdrawn | Federal Register, March 4, 2013 |
| June 18, 2009 | Both Geref applications | FDA's withdrawal of approval took effect | Federal Register, May 19, 2009 |
| March 4, 2013 | Both Geref products | FDA determined they were not withdrawn from sale for reasons of safety or effectiveness | Federal Register, March 4, 2013 |
Was sermorelin ever FDA-approved?
Yes. FDA approved Geref (sermorelin acetate) 0.05 mg on December 28, 1990 for evaluating whether the pituitary gland can secrete growth hormone. On September 26, 1997 it approved Geref 0.5 mg and 1.0 mg vials for idiopathic growth hormone deficiency in children with growth failure. EMD Serono held both applications.
Neither approval covered adult anti-aging, weight loss, muscle gain or sleep, which are the uses most online clinics advertise. FDA has never approved sermorelin for any of them.
Why is sermorelin no longer FDA-approved?
The manufacturer stopped selling it. EMD Serono told FDA in July 2008 that it was discontinuing the diagnostic product and in December 2008 that it was discontinuing the treatment vials, and it asked FDA to withdraw both applications. FDA announced the withdrawal on May 19, 2009, effective June 18, 2009.
FDA later examined the reason. On March 4, 2013 it determined that Geref was not withdrawn from sale for reasons of safety or effectiveness. FDA's product database still lists both Geref applications as discontinued and notes that determination.
Is the sermorelin sold online today FDA-approved?
No. With Geref off the market, the sermorelin offered by telehealth clinics is prepared by compounding pharmacies. FDA states that compounded drugs are not FDA-approved, which means it does not verify their safety, effectiveness or quality before they are marketed.
That status belongs to the product, whoever writes the prescription. FDA recall and warning records have included specific compounded sermorelin lots, so the dispensing pharmacy and its quality process are reasonable things to ask about before paying.
Is sermorelin legal, and can a doctor prescribe it?
Compounding is legal when it follows federal conditions. FDA describes drugs compounded by a licensed pharmacist in a state-licensed pharmacy, or by a physician, in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act. Meeting those conditions does not make a compounded product FDA-approved.
Whether to prescribe sermorelin is a licensed clinician's decision about an individual patient. A price comparison cannot make that call. Ask which pharmacy will fill the prescription and what the plan costs once any introductory price ends.
Is sermorelin a banned substance in sport?
Yes, for athletes covered by anti-doping rules. The World Anti-Doping Agency's Prohibited List names sermorelin among prohibited growth hormone-releasing hormone analogues, alongside CJC-1293, CJC-1295 and tesamorelin.
Anyone subject to drug testing should check with their sport's anti-doping organization before starting it. A prescription from a telehealth clinic does not change what the list prohibits.
Is any similar drug FDA-approved?
Tesamorelin is. It is another growth hormone-releasing hormone analogue, sold as Egrifta, and its approval is for reducing excess abdominal fat in adults with HIV who have lipodystrophy.
That approval does not extend to sermorelin, and it does not cover general weight loss. The two drugs have separate evidence and separate regulatory records.
Where can I compare current sermorelin providers?
The pages below compare public product and contract information. Some are labeled partner links. Any commission we receive does not change evidence claims or table order.
Partner link; we may earn a commission. Editorial order and findings do not change.
Compounded; not FDA-approved. Prescription required only if a licensed provider finds it appropriate.
Which sources support this answer?
Sources were checked October 11, 2026. They define the product, population and evidence limits used above; they do not determine individual suitability.
- FDA: discontinued Geref sermorelin determination
- Federal Register: 2009 withdrawal of approval of the Geref applications
- FDA: Drugs@FDA record for Geref (sermorelin acetate), listed as discontinued
- FDA: understanding the risks of compounded drugs
- FDA: Compounding and the FDA, questions and answers
- FDA: Olympia Pharmacy compounded-product recall
- FDA: Town and Country warning letter and sermorelin lot recall
- World Anti-Doping Agency: Prohibited List
- FDA: Egrifta (tesamorelin) prescribing information
These are products marketed in the longevity category, not established lifespan-extension treatments. Compounded drugs are not FDA-approved. This publication compares public information; a clinician must assess individual suitability. How we compare.