U.S. regulatory status

Sermorelin

Also known as GRF 1-29 · Geref · Sermorelin acetate

Compounding-legalCategory 1 of the interim 503A list — compoundable with a prescription

Is Sermorelin legal right now?

Sermorelin is treated as a Category 1 substance on the FDA's interim 503A bulks list, meaning state-licensed pharmacies may compound it with a valid prescription under the FDA's stated enforcement discretion while the agency completes its evaluation. It qualifies largely because it was a previously FDA-approved drug (Geref, a growth-hormone-releasing hormone analog approved in the 1990s) that the manufacturer discontinued in 2008 for commercial rather than safety reasons. This status is not fully final — Category 1 reflects enforcement discretion pending a permanent 503A determination. Separately, as a GHRH analog, sermorelin is prohibited at all times in sport under WADA category S2.

Compounding-legal: On the FDA 503A bulk-substances list; a licensed pharmacy may compound it. This is not the same as being an FDA-approved drug.

Current status held since Feb 19, 2019 · last verified Jul 7, 2026 (ET)

Primary source: FDA All 2 sources

Where it sits in the process

Nominated(completed)
Under review(completed)
Rulemaking(completed)
Compounding-legal(reached — this is the current status)

On the 503A list — a licensed pharmacy may compound it. This is not the same as being an FDA-approved drug.

What changed last

No recorded changes yet — this entry has held one status since it was added.

Status elsewhere

Sermorelin: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	Compounding-legal	Category 1 of the interim 503A list; compoundable with a valid prescription under enforcement discretion. Previously approved as Geref.
Australia (TGA)	Restricted	Prescription-only (Schedule 4) as a GHRH analog; obtainable via compounding pharmacy on prescription.
Sport / anti-doping (WADA)	Restricted	GHRH analogs fall under S2; prohibited at all times.

Sources & transparency

Sources for this entry

FDA — 503A bulk drug substances: Category 1 & Category 2 lists FDA · primaryFDA's interim 503A categories; sermorelin is treated as Category 1 (compoundable under enforcement discretion).
Frier Levitt — Regulatory status of peptide compounding (2025) analysisNames sermorelin as a peptide that can be compounded; defines Category 1.

Last verified by a human: Jul 7, 2026 (ET) · how we verify
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