The discontinued medicine most people mean is GEREF, a historical brand of sermorelin acetate injection. FDA later determined that the specified GEREF products had not been withdrawn from sale because of safety or effectiveness. That finding answers a narrow historical question; it does not mean that every current sermorelin preparation is FDA-approved.
The source is the FDA notice published March 4, 2013. It records the earlier approvals, the manufacturer's discontinuation requests, and FDA's subsequent review. Reading those events separately avoids turning “discontinued” into either proof of danger or a blanket assurance about today's products.
FDA determined the historical GEREF products were not withdrawn for safety or effectiveness reasons. That is not approval of current compounded products.
The short timeline
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| Period | What the FDA record describes |
|---|---|
| 1990 and 1997 | Separate approvals for diagnostic testing and pediatric growth-failure treatment |
| 2008 | Manufacturer notifications that the products were being discontinued |
| 2009 | Withdrawal of the relevant approvals, effective June 18 |
| 2013 | FDA determination that withdrawal was not for safety or effectiveness reasons |
The notice describes different historical presentations and uses. Neither was a general approval to reverse aging in otherwise healthy adults. The acetate explainer helps connect the names used in the record with the ingredient discussed today.
What “not for safety or effectiveness” means
FDA reviewed the historical question under the process used to determine whether a discontinued drug can remain a reference for a potential generic application. The notice says future applications would still have to satisfy other legal and regulatory requirements.
That is different from announcing a newly approved product. It is also different from approving a compounded vial or dissolving tablet sold by a modern telehealth program. When a website summarizes the decision as “FDA approved sermorelin,” ask which product, date, and indication it is describing.
What the notice does not settle
The record should not be stretched into a detailed explanation of the manufacturer's business decisions. It documents discontinuation and FDA's conclusion about the specified safety/effectiveness question. A claim about sales performance, manufacturing costs, or competitive strategy requires separate evidence.
It also cannot answer whether a particular adult should use sermorelin now. The relevant clinical questions include the diagnosis, the current formulation, and evidence for the proposed outcome. Our clinical-studies guide separates historical research interventions from today's product claims.
Compounding is a separate question
FDA explains that compounded drugs are not FDA-approved. Their use can meet an individual medical need, but compounding does not recreate an old drug approval merely because the ingredient name matches. A pharmacy's role and a manufacturer's historical application are different matters.
For current access, ask the prescribing service to identify the pharmacy and explain the basis for the specific prescription. Our FDA-status guide covers the distinction between ingredient history, finished-product approval, and compounding. A historical notice alone is not a complete answer to every present-day regulatory question.
How to read a provider's history claim
Look for a direct source and an accurately stated date. Check whether the advertised route is the same as the historical route and whether the cited patient population resembles the intended users. A study in children does not establish anti-aging benefits in adults simply because the ingredient appears in both contexts.
A useful provider explanation should move from history to the actual care being offered: why treatment is proposed, what uncertainty remains, and how response and safety will be reviewed. You should be able to understand those answers without needing to infer that an old brand name validates every current promise.
Sources & further reading
Provider pages describe offers; they do not independently establish treatment benefits. Sources checked September 20, 2026.
This article is education, not a diagnosis, prescription, or dosing plan. Discuss treatment and alternatives with a licensed clinician who knows your history. Compounded medications are not FDA-approved.