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Is sermorelin FDA approved?

By Dr. Paul C. Holmwood, MD. Published . 1 min read.

Not currently. Sermorelin was FDA-approved in the 1990s under the brand name Geref for growth hormone deficiency in children, but the manufacturer discontinued it in 2008 and no FDA-approved sermorelin product is on the market today. The sermorelin used now is compounded by licensed pharmacies under a prescription and is not FDA-approved.

What this means for you

Discontinued is not the same as banned. The brand was withdrawn by its manufacturer, not recalled over a safety finding, and the active ingredient remains available to compounding pharmacies under federal compounding law. That means each prescription is a patient-specific preparation with no federal review of the finished product, and its availability depends on current compounding rules, which change.

How it works at Biotech Lifestyle

Our providers explain that status plainly before prescribing. If sermorelin is appropriate for you, it is prepared by a licensed U.S. compounding pharmacy named in your account, and your provider monitors how you do on it.

Treatment pages: sermorelin, longevity medicine. Related reading: Sermorelin vs. Ipamorelin. All of our patient FAQs are collected on one page.

Frequently asked questions

Is sermorelin FDA approved?

Not currently. Sermorelin was FDA-approved in the 1990s under the brand name Geref for growth hormone deficiency in children, but the manufacturer discontinued it in 2008 and no FDA-approved sermorelin product is on the market today. The sermorelin used now is compounded by licensed pharmacies under a prescription and is not FDA-approved.

Why was Geref discontinued?

The manufacturer stopped producing it for commercial reasons. It was not pulled from the market over a safety recall.

Is compounded sermorelin legal?

Yes, when a licensed provider prescribes it and a licensed compounding pharmacy prepares it in line with current federal and state rules.

What to do next

A licensed provider reviews every assessment.

There is no charge to start.

Start a free online assessment with a licensed provider

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This article is for information only and is not medical advice. Compounded medications are prepared by licensed pharmacies for individual patients and are not FDA-approved. Prescriptions are issued only after evaluation by a licensed provider. Individual results vary.