Wasn’t sermorelin approved before?

Growth hormone is a body chemical that helps children grow.

Geref gained approval in December 1990 for a test of growth hormone release. September 1997 brought approval for treating children whose poor growth came from too little growth hormone.

The full ingredient name was sermorelin acetate. Acetate means the sermorelin is combined with another chemical to make a salt. The pharmacy rules below concern that ingredient; a different version needs its own check.

The maker stopped selling Geref and asked for its approvals to be canceled. June 18, 2009 was when that cancellation took effect.

In March 2013, the FDA said Geref had stopped being sold for reasons other than safety or how well it worked.

That decision explained why sales stopped. It did not approve any medicine offered now.

The US approval and pharmacy information on this page was checked on September 28, 2026.

With a valid prescription made out to you, a pharmacy licensed by the state may be able to prepare your sermorelin acetate. It must also meet the federal requirements for the ingredient and for making the medicine.

The maker of the raw ingredient must be FDA-registered, and the ingredient needs a document recording its test results. The pharmacy must meet any standards that apply to that ingredient.

This explains the general federal rules; it is not FDA clearance for a particular pharmacy or product. State rules can add limits.

This still makes an unapproved medicine. Before sale, the FDA has not assessed this medicine’s quality, safety, or how well it works.

So ask about the medicine you would receive. “It used to be approved” does not settle that question.