Can a pharmacy lawfully make sermorelin?

Compounding is making a medicine to order.

Food and Drug Administration (FDA) records were checked on 28 September 2026.

They suggest that a pharmacy licensed by the state may make sermorelin acetate for a patient named in a valid prescription.

This ingredient was in the former approved drug; federal rules let pharmacies use ingredients from approved drugs if they meet the other rules.

The raw ingredient must come from a maker on FDA's register.

It must come with a certificate of analysis, a document reporting checks on its quality.

The pharmacy must meet any official quality standard that applies to the ingredient, plus the other compounding rules and any state limits.

The records used here do not settle whether this ingredient has such an official quality standard.

The rules also restrict regular copying of a drug already on sale; the former Geref products are no longer sold.

This explanation applies general FDA rules to the ingredient in the old drug.

The records used here contain no FDA statement that specifically says a pharmacy may make sermorelin this way.

Ask the pharmacy to explain how its offer meets those rules.

This page cannot confirm that a particular offer is lawful.

An outsourcing facility is a larger maker that supplies medicines in batches, often to hospitals or clinics.

It prepares sterile medicines and does not need a separate prescription for each named patient.

Sterile means free of living germs.

FDA records were checked on 28 September 2026.

FDA is still deciding whether to put sermorelin acetate on the final list of raw ingredients these makers may use.

While FDA decides, its temporary policy says the agency plans no action based solely on use of this ingredient.

That only applies if the maker follows the policy's conditions.

These facilities must follow the same manufacturing quality rules as drug factories, and FDA inspects them.

Ask the maker how it meets the temporary policy's conditions as well as those quality rules. The ingredient's name on a list does not answer that.

Sermorelin acetate is not on the final allowed list.

This temporary promise not to take action is not product approval or a finding that every offer is lawful.

As of 26 September 2026, FDA does not review a made-to-order drug's safety, quality, or effectiveness before it is offered.

These ingredient rules concern the version named sermorelin acetate.

A different version cannot rely on that name just because it is also called sermorelin.