Is Sermorelin FDA Approved? GEREF History and 2026 Status

For your practice, the question has two parts: what FDA approved historically, and what the record shows today. This guide separates those records and identifies the compounding questions to review with your state boards and your own attorney.

Is sermorelin FDA approved?

No sermorelin product is FDA-approved and marketed today; Drugs@FDA shows two GEREF applications, both discontinued.

The openFDA Drugs@FDA dataset, last updated November 5, 2026, lists no other sermorelin application. That dated record is the basis for the current-status answer on this page.

At the company's request, FDA withdrew approval of both applications effective June 18, 2009. On March 4, 2013, FDA published a separate determination that the products had not been withdrawn for safety or effectiveness reasons. The withdrawal and the later determination answer different regulatory questions.

What was GEREF?

GEREF was the name of EMD Serono's sermorelin acetate products covered by two FDA applications.

FDA first approved NDA 19-863 on December 28, 1990, and NDA 20-443 on September 26, 1997. Sermorelin acetate is the ingredient name in those records.

The historical approvals covered a pediatric treatment use and a diagnostic use. The Federal Register GEREF determination gives the historical labeled uses and the approval history.

EMD Serono later notified FDA that the products were being discontinued and requested withdrawal of the applications. The timeline separates those company notices from FDA's announcement and the date withdrawal took effect.

Sermorelin regulatory timeline

Later checks include the FDA 503A category lists (opens in a new tab) updated May 14, 2026, and the HHS draft peptide policy (opens in a new tab) dated October 30, 2026. Sermorelin does not appear in either document.

What does the 2013 FDA determination mean, and what does it not mean?

The determination allows FDA to approve generic applications referring to GEREF if all other legal and regulatory requirements are met; it does not approve any current product or use.

These are abbreviated new drug applications, or ANDAs. The determination followed a citizen petition dated October 12, 2012. Permission for FDA to approve an application meeting the requirements is different from a record showing that FDA has approved one.

FDA keeps GEREF in the Orange Book's Discontinued Drug Product List. That list covers products discontinued for reasons other than safety or effectiveness. Sermorelin also does not appear in 21 CFR 216.24 (opens in a new tab), the list of products withdrawn for safety or effectiveness that cannot be compounded under the 503A or 503B exemptions.

Neither point establishes approval of a current product. The October 30, 2026 Drugs@FDA data shows no other sermorelin application. Compounded drugs remain unapproved, and FDA does not verify their safety, effectiveness or quality before marketing.

Can sermorelin be compounded?

Whether a specific compounded sermorelin product meets section 503A is a fact-specific legal question this page does not answer.

FDA describes three 503A bulk-substance pathways (opens in a new tab). Their conditions matter:

• If an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph exists, the substance must comply with it and the USP chapter on pharmacy compounding.
• If no applicable USP or NF monograph exists, the substance must be a component of an FDA-approved drug product.
• If neither of those conditions applies, the substance must appear on FDA's 503A bulks list.

Under FDA section 503A guidance (opens in a new tab), a compounded drug must be compounded for an identified individual patient based on a valid prescription order. FDA also says compounded drugs should only be used when an FDA-approved drug cannot meet the patient's medical needs.

Sermorelin does not appear on FDA's 503A category lists updated May 14, 2026. It is also outside the six peptides covered by the October 30, 2026 HHS draft policy. Those checks do not resolve the full 503A question for a specific product. For context on the two sections, see our 503A and 503B pharmacy guide.

Is sermorelin legal?

This page does not determine whether a specific sermorelin product is legal or illegal.

For a compounding review, ask your own attorney to assess the applicable bulk-substance pathway and the patient-specific prescription condition. Keep the question tied to the specific product and circumstances under review.

State boards of pharmacy have primary day-to-day oversight of state-licensed pharmacies that are not registered as 503B outsourcing facilities. Check with your state boards and your own attorney before acting on a general explanation of federal rules.

How is sermorelin different from tesamorelin?

Sermorelin has no FDA-approved, marketed product today, while Drugs@FDA lists Egrifta (opens in a new tab) (tesamorelin acetate) as approved and prescription.

For a sermorelin vs tesamorelin comparison, keep the approval records separate. Egrifta was approved November 10, 2010, and is listed under BLA 022505. Drugs@FDA notes that the former NDA was deemed a BLA on March 23, 2020. The two GEREF entries are discontinued NDAs.

FDA says biological products are not eligible for the compounding exemptions under sections 503A and 503B. The table compares regulatory records only.

What should a practice check before discussing sermorelin with patients?

Check the product's regulatory status, the applicable prescription condition, promotional claims and state requirements with your own attorney.

• Product category: Establish whether the product is represented as approved, compounded or research use only. Check the approval record rather than treating those descriptions as interchangeable.
• Research labeling: A research-use-only label does not establish legality for patients. In a June 17, 2026 warning letter (opens in a new tab), FDA found products were intended as drugs for human use despite that labeling.
• Prescription condition: For 503A, verify that compounding is for an identified individual patient based on a valid prescription order.
• Promotion: Prescription drug promotion by or for compounders must be truthful, accurate and non-misleading. Under FTC Health Products Compliance Guidance (opens in a new tab), health benefit or safety claims require competent and reliable scientific evidence. Animal or laboratory studies alone are insufficient.
• State review: Check with your state boards and your own attorney. Include the state pharmacy board's oversight role in that review.

Related reading

• Are Peptides Legal? FDA Status and Compounding Rules
• Telehealth Regulation News: How to Ensure Virtual Compliance
• How to Pick the Right Medical Spa Lawyer for Your Clinic
• Med Spa Laws by State: Ownership and Licensing

Sources

• Federal Register: GEREF withdrawal determination (opens in a new tab), checked November 6, 2026.
• FDA: Drugs@FDA GEREF NDA 19-863 (opens in a new tab), checked November 6, 2026.
• FDA: Drugs@FDA GEREF NDA 20-443 (opens in a new tab), checked November 6, 2026.
• eCFR: 21 CFR 216.24 withdrawn drug products (opens in a new tab), checked November 6, 2026.
• FDA: Bulk substances nominated under section 503A (opens in a new tab), checked November 6, 2026.
• HHS: Draft 503A peptide enforcement policy (opens in a new tab), checked November 6, 2026.
• FDA: Bulk substances under section 503A (opens in a new tab), checked November 6, 2026.
• FDA: Compounding questions and answers (opens in a new tab), checked November 6, 2026.
• FDA: Section 503A pharmacy compounding guidance (opens in a new tab), checked November 6, 2026.
• FDA: Drugs@FDA Egrifta BLA 022505 (opens in a new tab), checked November 6, 2026.
• FTC: Health Products Compliance Guidance (opens in a new tab), checked November 6, 2026.
• FDA: Research labeling warning letter (opens in a new tab), checked November 6, 2026.