Sermorelin: legal status and FDA history

Short answer: sermorelin acetate was the active ingredient in GEREF, a drug FDA approved and that was later withdrawn from sale. In 2013 FDA determined that GEREF was not withdrawn for reasons of safety or effectiveness [1]. Sermorelin is not one of the six peptides in the 2026 HHS policy, and it is not on FDA’s list of substances nominated for the 503A bulks list [3].

At a glance

FDA history	Active ingredient of GEREF, an approved drug, now withdrawn from sale [1]
Why it was withdrawn	FDA found it was not for safety or effectiveness reasons (2013) [1]
2026 HHS peptide policy	Not covered (not on Appendix A) [2]
FDA 503A nomination list	Not listed [3]
Last checked	November 6, 2026

Why GEREF’s history matters for compounding

Under section 503A, a pharmacy may compound with a bulk ingredient that has a USP or NF monograph, or that is a component of an FDA-approved drug, or that is on FDA’s 503A bulks list [2]. Sermorelin acetate was a component of GEREF [1]. We have not found an FDA statement that says how this rule applies to sermorelin today, so ask the pharmacy which rule it relies on, and check it with our pharmacy checklist.

What the 2013 notice says

FDA reviewed the available evidence and found that both GEREF products were not withdrawn from sale for reasons of safety or effectiveness. That finding lets FDA approve generic versions (ANDAs) that refer to GEREF, if all other legal requirements are met [1]. It is not a finding about any compounded product.

What is not known

We have not found a current FDA review of sermorelin as used in compounding. Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed [2]. Talk to a licensed clinician before you use it.

Change log

• November 6, 2026: page created.