U.S. regulatory status

Sermorelin

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

Compounding-legalNot on any 503A list; compounded as a component of Geref, an FDA-approved drug withdrawn in 2009 for non-safety reasons

Is Sermorelin legal right now?

Sermorelin is a synthetic analog of growth hormone-releasing hormone that the FDA approved as Geref in 1990 (a diagnostic, NDA 19-863) and 1997 (growth hormone deficiency in children, NDA 20-443).

EMD Serono discontinued both in 2008 and asked the FDA to withdraw the approvals, effective June 18, 2009. On March 4, 2013 the FDA determined that Geref was not withdrawn for safety or effectiveness reasons, so it stays in the Orange Book’s discontinued list.

Sermorelin is not on the 503A bulks list and has never appeared in the FDA’s interim 503A categories. State-licensed 503A pharmacies compound it on prescription as a component of an FDA-approved drug, a route that needs no bulks-list entry; the FDA has not said whether an approval withdrawn at the sponsor’s request still counts, and no FDA warning letter to a pharmacy has challenged that.

Because Geref is not marketed, the essentially-copies limit does not apply. Selling it as a “research” peptide is not lawful: on December 10, 2024 the FDA warned Xcel Research that its sermorelin was an unapproved new drug.

No FDA review of sermorelin is pending.

Compounding-legal: A licensed pharmacy may compound it on prescription: it is on the FDA 503A bulk-substances list or is an ingredient of an FDA-approved drug that is not on the market. This is not the same as being an FDA-approved drug.

Verified Oct 15, 2026 (ET) · status held since Mar 4, 2013

Primary source: FDA All 10 sources

Where it sits in the process

Not on the 503A list, and it does not need to be. A licensed pharmacy may compound it on prescription as an ingredient of an FDA-approved drug. The status above says which drug, and what is still not allowed.

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	Not on the 503A bulks list or any interim category. Compounded as a component of Geref (NDAs 19-863, 20-443), whose approvals were withdrawn at the sponsor’s request effective Jun 18, 2009; FDA found (Mar 4, 2013) it was not withdrawn for safety or effectiveness. FDA has not addressed whether a withdrawn approval still qualifies.
Australia (TGA)	Restricted	Schedule 4 (prescription-only), named individually in the Poisons Standard (October 2026), and possession without authority is illegal (Appendix D). No product on the ARTG.
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	Named in S2.2.4 (GHRH and its analogues) on the 2026 and 2027 Prohibited Lists; 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

FDA warning letters

2 FDA warning letters mention sermorelin, from Jan 26, 2022 to Dec 10, 2024.

Xcel Research LLC Dec 10, 2024 · Unapproved New Drugs / Misbranded
Innoveix Pharmaceuticals Inc Jan 26, 2022 · Compounding Pharmacy / Adulterated Drug Products

A warning letter is the FDA telling one company it believes the company broke federal law. It does not change the status above. All warning letters, by compound

Sources & transparency

Sources for this entry

FDA - Bulk drug substances used in compounding under section 503A FDA · primary503A pharmacies may use bulk substances that are components of FDA-approved drug products; sermorelin is not in any FDA 503A category.
Federal Register - Determination that Geref was not withdrawn for reasons of safety or effectiveness (Mar 4, 2013) Federal Register · primaryFDA keeps Geref in the Orange Book’s discontinued drug product list.
Federal Register - Withdrawal of approval of NDAs 19-863 and 20-443 (Geref), effective Jun 18, 2009 Federal Register · primaryWithdrawn at the holder’s request because the products were no longer marketed.
Drugs@FDA - NDA 020443 (Geref) FDA · primarySermorelin acetate, approved Sep 26, 1997 (orphan); marketing status Discontinued.
FDA warning letter - Xcel Research LLC (Dec 10, 2024) FDA · primaryCalls the seller’s “SERMORELIN” products unapproved new drugs.
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.
WADA - 2027 Prohibited List (in force Jan 1, 2027) WADA · primaryS2.2.4 names sermorelin among GHRH analogues; prohibited at all times.
Frier Levitt - Regulatory status of peptide compounding (2025) AnalysisNames sermorelin as an example of a peptide that can be compounded (not as a Category 1 substance).

Last verified by a human: Oct 15, 2026 (ET) · how we verify
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