Sermorelin is not FDA-approved today in any product you can buy, but it was approved once. The brand was GEREF, and its history is the reason a pharmacy may still compound sermorelin now.
What a prescription costs to obtain is in sermorelin prescription, and what a month costs is in the sermorelin cost guide.
GEREF: two approvals, then a withdrawal
December 28, 1990
Diagnostic ampule approved
NDA 19-863, to test the pituitary's ability to secrete growth hormone.
September 26, 1997
Treatment vials approved
NDA 20-443, for idiopathic growth hormone deficiency in children with growth failure.
June 18, 2009
Approvals withdrawn
At the holder's request, after it discontinued both products in 2008.
March 4, 2013
Determination published
Not withdrawn for reasons of safety or effectiveness.
FDA approved the diagnostic ampule in 1990 and the treatment vials in 1997, both held by EMD Serono[1]. The vials were indicated for idiopathic growth hormone deficiency in children with growth failure[1]. Drugs@FDA lists both applications, with the products marked discontinued[2][3].
In 2008 the holder told FDA it was discontinuing both products and asked FDA to withdraw the applications[1]. FDA withdrew them, effective June 18, 2009[1].
The 2013 determination
A citizen petition asked FDA whether GEREF had been withdrawn for safety or effectiveness reasons[1]. On March 4, 2013, FDA published its answer: it had not been[1]. FDA said it reviewed its own records, the literature and postmarketing adverse event data before deciding[1].
The notice states the practical effect for generic makers. It allows FDA to approve abbreviated applications that refer to GEREF, if every other requirement is met[1]. Drugs@FDA lists no sermorelin application other than the two GEREF records[2][3].
Why a pharmacy may compound it
Section 503A lets a licensed pharmacy compound from a bulk substance in one of three ways, and one of them is a substance that is a component of an FDA-approved drug[4]. This site’s compound register records sermorelin’s basis in those terms: Component of an FDA-approved drug (GEREF, sermorelin acetate). FDA determined in 2013 that GEREF was not withdrawn from sale for reasons of safety or effectiveness.
Compounding still needs a prescription for an identified patient[4]. And the product a pharmacy makes is not FDA-approved: FDA does not verify its safety, effectiveness or quality before it is sold[5]. The two pharmacy tiers are explained in the compounded peptides guide, and the wider legal picture is in are peptides legal.
What compounded sermorelin costs
Compounded sermorelin has a typical price of $185 a month, across 137 sellers that publish a monthly figure, from $99 to $349. Prices were read through September 2026.
That figure is the medication. A seller may add a visit, labs or shipping, and some fold those into the monthly price; the price boards show each seller’s figure, and the reviews record what sits outside it.
The question to ask a seller
Ask which pharmacy compounds the sermorelin and in which state it is licensed. A seller that calls its sermorelin FDA-approved is describing GEREF, which its maker discontinued in 2008.