Past approval. Different rules today.

What is available today?

As of September 2026, there is no marketed FDA-approved sermorelin product in the US.

The US drug agency is called the Food and Drug Administration, abbreviated FDA.

FDA does not check the quality, effects or safety of a pharmacy-made drug before it reaches the market.

What happened to the old medicine?

Sermorelin (Geref) had approvals for a hormone test and for children growing too slowly because they had too little growth hormone. Growth hormone is a body signal involved in growth.

Geref left the market at the maker’s request, and its approvals ended on June 18, 2009.

In March 2013, FDA concluded that safety or effectiveness was not the reason Geref left the market.

The notices do not give the maker’s business reason for stopping sales. FDA’s finding does not approve a product offered today.

Sermorelin has no adult-use approval, as of September 2026.

What may a pharmacy prepare?

As of September 2026, pharmacies with a state licence may prepare sermorelin acetate for the patient named in a valid prescription if both pharmacy and ingredient meet the required rules. “Acetate” identifies the chemical version of the drug ingredient used in Geref, rather than an extra treatment.

The ingredient must come from a maker registered with FDA and have a valid certificate of analysis, a report of the ingredient’s test results. It must meet any required published quality standards. State pharmacy law can add limits.

The ingredient rule permits use of an ingredient from an approved drug, even when that drug is no longer sold. Sermorelin acetate was the ingredient in Geref.

FDA’s general ingredient rule supports this possibility, but the FDA documents checked do not confirm it for sermorelin by name. That is why the answer is “may”, rather than a promise that a particular pharmacy’s product meets the law.

State rules may add limits, and the finished medicine still has no FDA approval.

Ask: “Which pharmacy makes it? Is it using the rules for a patient’s prescription or the rules for a larger facility making batches? How does it meet every requirement for this medicine?”

What about larger compounding facilities?

As of September 2026, FDA still has sermorelin acetate under review for large compounding sites.

FDA does not plan to take enforcement action over use of this raw ingredient if the facility meets its temporary policy’s conditions. This is a choice about enforcing the ingredient rule, rather than a final decision to allow the ingredient.

As of September 2026, sermorelin acetate is not on the final list of raw ingredients allowed for these larger facilities.

This policy is not drug approval.

As of September 2026, these larger facilities must register with FDA, follow the quality rules used by drug factories and undergo FDA inspections.

Ask the facility to show the current FDA policy and explain how it meets each condition for sermorelin acetate. Calling itself an “outsourcing facility” does not answer that question.

Read approval claims carefully→