Is Sermorelin Legal? FDA Status and Regulations Explained (2026)

Key Takeaways

• Sermorelin is not FDA-approved for any specific indication but is listed as a Category 1 compoundable substance.
• 503A and 503B pharmacies can legally compound Sermorelin under specific conditions.
• Sermorelin is available by prescription only and cannot be sold over-the-counter.
• Patients should verify that clinics offering Sermorelin operate legally and be aware of potential red flags.

Current FDA Status

Sermorelin, a growth hormone-releasing hormone (GHRH) analog, is not FDA-approved for any specific therapeutic indication. However, it is listed on the FDA's compounding bulk drug substance list as a Category 1 substance, meaning it can be compounded by licensed pharmacies under certain conditions. This status was confirmed in the Federal Register notice (FDA-2019-N-3767).

Compounding Status

Sermorelin can be compounded by both 503A and 503B pharmacies. Category 1 designation allows compounding when there is a clinical need and the compounded product is not a copy of a commercially available drug. Pharmacies must adhere to strict guidelines to ensure safety and efficacy, including sourcing Sermorelin from FDA-registered facilities.

Enforcement Actions

To date, there have been no major DOJ prosecutions or FDA warning letters specifically targeting Sermorelin. However, the FDA closely monitors compounding practices to ensure compliance with federal regulations. Pharmacies found in violation may face enforcement actions, including fines and license revocations.

Prescription vs. Over-the-Counter vs. Research Use

Sermorelin is available by prescription only. It cannot be legally sold over-the-counter. Some suppliers market Sermorelin for "research use only," a designation that legally restricts its sale to non-human research purposes. This means it should not be used for self-administration or human clinical applications without a prescription from a licensed healthcare provider.

State-Level Variations

While federal regulations govern the compounding and prescription of Sermorelin, some states may have additional requirements or restrictions. Patients and providers should consult state pharmacy boards for specific regulations.

What "Off-Label" Actually Means

Off-label prescribing refers to the use of FDA-approved drugs for unapproved indications. Since Sermorelin is not FDA-approved for any indication, its prescription is not considered off-label but rather the use of an unapproved drug. Healthcare providers must assess the risks and benefits and obtain informed consent from patients.

What This Means for Patients

Patients considering Sermorelin therapy should ensure that their provider is licensed and operates within legal boundaries. Verify the clinic's credentials and ask about the source of Sermorelin. Be cautious of clinics that offer Sermorelin without a prescription or fail to provide comprehensive information about its use and potential side effects.

Legal Alternatives

For those seeking alternatives to Sermorelin, Ipamorelin is another GHRH analog that may be compounded under similar regulations. Patients should discuss options with their healthcare provider to determine the best course of action.

FAQ

Is Sermorelin FDA-approved?

No, Sermorelin is not FDA-approved for any specific therapeutic use.

Can Sermorelin be legally compounded?

Yes, Sermorelin is a Category 1 compoundable substance, allowing compounding in licensed 503A and 503B pharmacies.

Is a prescription required for Sermorelin?

Yes, Sermorelin requires a prescription from a licensed healthcare provider.

Can I buy Sermorelin over-the-counter?

No, Sermorelin cannot be legally sold over-the-counter.

What should I look for in a Sermorelin clinic?

Ensure the clinic is licensed, verify the source of Sermorelin, and confirm that a prescription is required for treatment.

Medical Disclaimer: This content is for informational purposes only and does not constitute medical advice. Consult a licensed healthcare provider before starting any treatment. Legal status can change and was last verified February 2026.