MyPeptideMatch
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.
