Sermorelin was FDA-approved as Geref, then withdrawn. What the 2013 determination still means for compounding

By · Published · Updated · 7 min read · 8 sources, 8 checked at the source

AI-generated image: a fit man in a home gym holds a water bottle beside a counter with a sealed vial labeled sermorelin acetate and a hardcover book.

Search "is sermorelin FDA approved" and you'll get answers that sound definitive and contradict each other. One camp says yes, because it once had approved products. Another says no, because those products are gone. Both are reaching for a piece of a longer paper trail: approvals in the 1990s, a 2008–2009 exit from the market, a 2013 Federal Register determination that the exit was not a safety-or-effectiveness finding, and today's compounding category lists. Here's that history, without repeating the research evidence page we already published.

Facts are as of November 6, 2026. Sources, with retrieval dates, are at the bottom.

Updated November 10, 2026. For how sermorelin compares with glutathione and NAD — the three names in Hims's first Peptides+ phase — see our side-by-side research and status page.

The status path in five lines

  • Geref (sermorelin acetate) held two NDAs: one approved December 28, 1990, and one September 26, 1997. [V]
  • The manufacturer discontinued the products in 2008; FDA withdrew the NDA approvals effective June 18, 2009. [V]
  • On March 4, 2013, FDA determined the market exit was not a safety-or-effectiveness finding, which keeps ANDA pathways open when other requirements are met. [V]
  • As of our November 6, 2026 check, DailyMed lists no marketed sermorelin label. [V]
  • Sermorelin acetate appears on FDA's 503BSection of federal drug law for outsourcing facilities: larger compounders that register with FDA and must follow drug-manufacturing quality rules. Glossary entry Category 1An interim FDA group of nominated bulk ingredients that FDA generally does not object to pharmacies using while its review continues. Not an approval. Glossary entry list (updated March 21, 2025) as a component of FDA-approved drugs; we did not find it on the 503ASection of federal drug law covering compounding by state-licensed pharmacies and doctors, usually for a prescription written for one patient. Glossary entry Category list updated May 14, 2026. [V]

When Geref was a marketed medicine

FDA's 2013 Federal Register notice (2013-04827) is the cleanest primary write-up of the approvals. [V] Geref (sermorelin acetate) injection in the diagnostic amp presentation (listed as 0.05 mg base/amp) sat under NDA 19-863 at EMD Serono; first approval was December 28, 1990, for checking whether the pituitary could release growth hormone. [V] The treatment vials (listed as 0.5 and 1.0 mg base/vial) sat under NDA 20-443, approved September 26, 1997, for idiopathic growth hormone deficiency in children with growth failure. [V]

Those milligram figures are product-strength identifiers in the determination's title and Orange Book listing. They are not instructions for use. [V]

openFDA's Drugs@FDA records still show both applications, with marketing status Discontinued, and they carry FDA's note pointing to the Federal Register finding that the discontinuation was not a safety-or-effectiveness call. [V]

How it left the market

In letters dated July 11 and December 2, 2008, EMD Serono told FDA it was discontinuing the products and requested withdrawal of the NDAs. [V] FDA moved them onto the Orange Book discontinued list, and a May 19, 2009 Federal Register notice (74 FR 23407) said approval of both NDAs would end as of June 18, 2009. [V]

That is a market exit and an approval withdrawal. It is not, by itself, a finding that the drug was unsafe or ineffective. That question got its own later notice.

The 2013 determination: why it still matters

On October 12, 2012, Alvin J. Lorman filed a citizen petition (FDA-2012-P-1071) asking FDA to say whether the 0.5 and 1.0 mg base/vial products were withdrawn for safety or efficacy reasons. [V] FDA also looked, on its own initiative, at the 0.05 mg base/amp product. [V]

In the March 4, 2013 notice, FDA said that after reviewing the petition, its own files, literature, and postmarketing adverse-event information available at the time, it determined under 21 CFR 314.161 that the Geref exit was not a safety-or-effectiveness withdrawal. [V] The Agency said the products stay on the Orange Book discontinued list, and that ANDAs that reference those listed drugs can still be approved when every other legal and regulatory condition is satisfied. [V]

“were not withdrawn from sale for reasons of safety or effectiveness”

Federal Register 2013-04827, March 4, 2013

In Hatch-Waxman terms, that finding keeps a generic pathway theoretically open. It does not put a sermorelin product back on pharmacy shelves by itself, and it is not a new approval. [V]

Where compounding lists put it today

Compounding status is a separate ledger from the old NDA story.

503B (outsourcing facilities). FDA's bulk-substance category PDF for section 503B, updated March 21, 2025, lists Sermorelin Acetate in Category 1 (under evaluation), with the double-asterisk note that it is a component of FDA-approved drugs. [V] Category 1 is an interim enforcement-policy bucket while FDA evaluates nominations; it is not a final bulks-list decision and not an approval of any compounded product. [V]

503A (state-licensed pharmacies / physicians). We searched FDA's 503A category PDF updated May 14, 2026, and did not find sermorelin. [V] Absence from that PDF is not the same as a ban, and it is not the same as a green light; it means this substance isn't sitting in those three named categories on that dated list. [V]

Category 2An interim FDA group of nominated bulk ingredients that FDA has flagged for possible significant safety risks while its review continues. Glossary entry safety page. We did not find a sermorelin entry on FDA's "significant safety risks" compounding page in tonight's check. [V]

Marketed label. A DailyMed search for sermorelin on November 6, 2026, returned zero SPL labels. [V]

Our longer sermorelin vs growth hormone evidence page covers the research record and also sketches this compounding box; this page is the regulatory history and status check. For how Category 1 language works in general, see the compounding categories explainer. Telehealth companies that mention sermorelin in product plans are describing business plans, not new FDA approvals — our Hims Peptides+ note is one example of that distinction.

What people get wrong

"FDA approved it, so today's compounded sermorelin is FDA approved." The approved products were Geref under specific NDAs. Those approvals were withdrawn in 2009. Compounded preparations are not FDA-approved drugs. [V]

"Withdrawn means FDA found it unsafe." The 2013 determination says the opposite for these products: the exit was not a safety-or-effectiveness finding. [V]

"Category 1 means FDA signed off on compounding it for anyone." Category 1 is an interim evaluation bucket with enforcement-policy conditions for outsourcing facilities. It is not a product approval. [V]

Limits and unknowns

We have not opened a current Orange Book PDF line-by-line beyond the Drugs@FDA / FR trail summarized here. [U] We also have not verified whether any ANDA for sermorelin acetate has been submitted or approved since 2013; openFDA's Drugs@FDA results we pulled tonight still show the discontinued Geref NDAs, not a new active ANDA row. [V] State pharmacy-board rules can add requirements on top of federal compounding law; we didn't survey fifty states. [U]

Peptide Policy Watch

Sermorelin was FDA-approved as Geref, then withdrawn. What the 2013 determination still means for compounding

Published November 6, 2026 · https://peptidepolicywatch.com/2026/11/06/sermorelin-geref-fda-approval-withdrawal-compounding-status/

Printable checklist

Questions that separate history from today's bottle

General questions drawn from this page, to take to a clinician or pharmacist who knows your health history.

  1. Is there a currently marketed, FDA-approved sermorelin product, or is this a compounded preparation?
  2. If compounded, is the pharmacy operating under 503A or 503B, and where does sermorelin sit on the category list that pharmacy follows?
  3. How does this product's regulatory path differ from an approved growth-hormone medicine on DailyMed?

Print view Select it, then use your browser’s Print command to print only this box.

What "approved once" actually buys you

Sermorelin is unusual among wellness-market peptides because it really did clear FDA as Geref, left the market for business reasons documented in the FR notice, and then got an explicit "not for safety or effectiveness" determination that preserves ANDA eligibility. That history is checkable. It still doesn't turn a compounded vial into an approved drug, and it doesn't freeze the compounding lists in place forever. If FDA moves sermorelin between categories, posts a new PCACPharmacy Compounding Advisory Committee: outside experts who advise FDA on compounding questions. Its votes are recommendations, not decisions. Glossary entry review, or an ANDA lands, this page is where we'll note it. For the science half of the story, stay with the evidence page; for the wider "what does legal mean" map, see are peptides legal.

Sources (retrieved November 6, 2026)

  1. Federal Register, "Determination That GEREF (Sermorelin Acetate) Injection… Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness," 78 FR 14095, document 2013-04827, March 4, 2013 [V] — https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams
  2. openFDA Drugs@FDA, applications NDA019863 and NDA020443 (Geref / sermorelin acetate; Discontinued; FR determination note), data last_updated November 5, 2026 [V] — https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:GEREF
  3. DailyMed SPL search for drug_name=sermorelin (0 results), checked November 6, 2026 [V] — https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=sermorelin
  4. FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B… category PDF, updated March 21, 2025 (Sermorelin Acetate** in Category 1) [V] — https://www.fda.gov/media/94164/download
  5. FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A… category PDF, updated May 14, 2026 (no sermorelin entry found) [V] — https://www.fda.gov/media/94155/download
  6. FDA, "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks" page (no sermorelin entry found in tonight's check) [V] — https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  7. FDA, Bulk Drug Substances Used in Compounding Under Section 503B hub [V] — https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503b-fdc-act
  8. Peptide Policy Watch, sermorelin vs growth hormone evidence page [V] — https://peptidepolicywatch.com/2026/10/26/sermorelin-vs-growth-hormone-what-the-evidence-shows/
Cite or link to this page

Peptide Policy Watch staff. “Sermorelin was FDA-approved as Geref, then withdrawn. What the 2013 determination still means for compounding.” Peptide Policy Watch. Published November 6, 2026. Updated November 10, 2026. https://peptidepolicywatch.com/2026/11/06/sermorelin-geref-fda-approval-withdrawal-compounding-status/

Link: https://peptidepolicywatch.com/2026/11/06/sermorelin-geref-fda-approval-withdrawal-compounding-status/

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