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Is Sermorelin legal? FDA status and US regulatory standing
Current status
Not FDA-evaluated. Sermorelin has not been evaluated by the FDA as a drug. Sermorelin is among the most legally clear compoundable peptides in the U.S. It is on the 503A bulk substances list and can be compounded by licensed pharmacies under a physician's prescription. It is widely prescribed for growth hormone deficiency and anti-aging research programs.
Primary source: www.accessdata.fda.gov
Federal legal status
FDA approval status
Sermorelin acetate was FDA-approved as Geref (for diagnosis of GH deficiency in children, 1990). The original Geref product was withdrawn from the market by the manufacturer, not by FDA order. Sermorelin acetate remains on the 503A bulk substances list and can be lawfully compounded by 503A pharmacies.
Compounding pharmacy rules (federal)
Sermorelin is on the FDA 503A bulk substances list (Category 1), meaning it can be lawfully compounded by state-licensed 503A compounding pharmacies under a valid prescription. It is also commonly compounded by 503B outsourcing facilities. It is a legally accessible compounded peptide when properly prescribed and dispensed.
Also known as
GHRH (1–29) · Geref
About Sermorelin
Sermorelin is a synthetic analog of growth hormone-releasing hormone (GHRH), specifically the first 29 amino acids. It stimulates the pituitary gland to produce and release growth hormone. Unlike direct HGH administration, sermorelin acts through the body's own regulatory mechanisms.
Frequently asked questions
- Is sermorelin legal to prescribe and compound?
- Yes. Sermorelin is on the FDA 503A bulk substances list and can be lawfully compounded by licensed 503A pharmacies under a valid prescription from a licensed healthcare provider.
- Does sermorelin require a prescription?
- Yes. Sermorelin requires a prescription from a licensed provider. It cannot legally be purchased over the counter or dispensed without a valid prescription.
State-level notes
Compounding and prescribing rules are administered by state pharmacy boards and vary by state. Federal FDA status (above) applies nationwide.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .