Sermorelin: FDA and compounding status

Quick answer

Sermorelin is an FDA-approved drug and is not on FDA's 503A Bulks List. Section 503A records it as "Not nominated" (May 14, 2026) and section 503B as "Category 1" (March 21, 2025). No PCAC recommendation is on file and the committee is advisory; verified September 16, 2026.

By Peptides.NYC Editorial TeamPublished September 16, 2026

Verified against FDA's bulk substances page on September 16, 2026. Every field below links the document it came from.

Current status

Sermorelin

FDA approval

FDA approved

FDA approved GEREF (sermorelin acetate) under NDA 019863 on December 28, 1990 as a new molecular entity. Drugs@FDA shows the product as Discontinued, with a Federal Register determination that it was not discontinued or withdrawn for safety or effectiveness reasons.

Sources

Drugs@FDA, NDA 019863 (GEREF, sermorelin acetate) (U.S. Food and Drug Administration, retrieved 2026-09-16)

Section 503A

Not nominated

As stated on the cited document, dated May 14, 2026.

The substance appears in none of the categories on that nomination document, as of the document's own date.

Appears in none of the three categories on FDA's section 503A nomination document as of that document's own date.

Sources

FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act, updated May 14, 2026 (U.S. Food and Drug Administration, retrieved 2026-09-16)

Section 503B

Category 1

As stated on the cited document, dated March 21, 2025.

FDA does not intend to take action against compounding with this substance while it evaluates the nomination. That is enforcement discretion under an interim policy — it is not inclusion on the Bulks List.

FDA lists "Sermorelin Acetate" in 503B category 1 and marks it with the two asterisks it uses for category 1 substances that are components of FDA-approved drugs.

Sources

FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025 (U.S. Food and Drug Administration, retrieved 2026-09-16)

Verified against FDA's bulk substances page on September 16, 2026.

Timeline

Every dated event on file for Sermorelin, newest first, with the document it came from.

March 21, 2025Status change
FDA's categorized 503B nomination list, updated this date, placed sermorelin acetate in category 1 and flagged it as a component of an FDA-approved drug.
Sources
- FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act, updated March 21, 2025 (U.S. Food and Drug Administration, retrieved 2026-09-16)
December 28, 1990Status change
FDA approved GEREF (sermorelin acetate) under NDA 019863.
Sources
- Drugs@FDA, NDA 019863 (GEREF, sermorelin acetate) (U.S. Food and Drug Administration, retrieved 2026-09-16)

Related guides

Frequently asked questions

Is Sermorelin legal to compound?

On FDA's section 503A list, Sermorelin is recorded as "Not nominated" as of May 14, 2026. On FDA's section 503B list, Sermorelin is recorded as "Category 1" as of March 21, 2025. Sermorelin is not on FDA's 503A Bulks List: that list is established by notice-and-comment rulemaking, and none of the categories above is inclusion on it. Compounding is governed by federal and state law together, and a pharmacy or outsourcing facility answers to both. This page reports what FDA has published; it is not legal or medical advice.

Was Sermorelin reviewed by PCAC?

This tracker cites no Pharmacy Compounding Advisory Committee record for Sermorelin. PCAC's role is advisory: FDA must still complete notice-and-comment rulemaking before anything is added to the 503A Bulks List.

Is Sermorelin FDA-approved?

Disclaimer: This page is a record of what regulators have published about Sermorelin. It is for educational purposes only, it is not medical or legal advice, and it is not a recommendation to use or compound any substance. Regulatory status changes; check the linked primary sources and consult your healthcare provider.