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.

Verified Sep 22, 2026 (ET) · status held since Feb 19, 2019

Primary source: FDA All 5 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.
United Kingdom (MHRA)	Restricted	No UK marketing authorisation; supply for human use treated as an unlicensed medicine.
European Union (EMA)	Restricted	No centralised EU marketing authorisation (absent from the Union Register); sale as a medicine is unlawful EU-wide, with enforcement handled at member-state level.
Canada (Health Canada)	Restricted	Named on the Prescription Drug List (‘Sermorelin or its salts’, effective 2013-12-19); no product currently authorized in the Drug Product Database.
Sport / anti-doping (WADA)	Restricted	GHRH analogs fall under S2; prohibited at all times.

The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it

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).
MHRA Products database - search: sermorelin UK gov · primaryBasis for the United Kingdom (MHRA) status row.
Health Canada Prescription Drug List - Human Use Health Canada · primaryBasis for the Canada (Health Canada) status row.
Union Register of medicinal products (European Commission) EU · primaryBasis for the European Union (EMA) status row.
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: Sep 22, 2026 (ET) · how we verify
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