Sermorelin: Regulatory Status
Current legal and regulatory status for Sermorelin across jurisdictions. This page reflects the most recent verified information and is updated as regulatory actions occur.
Back to Sermorelin overviewUnited States
Pending Reclassification
Prescription required
Recent Regulatory Action
Manufacturer discontinuation 2008; compounding availability continues
Was FDA-approved 1997-2008 (Geref). Discontinued by manufacturer for commercial reasons. Now available as compounded medication. Category 2 under current FDA compounding guidance.
What This Means
Pending reclassification does not mean currently legal to compound.
Until formal FDA guidance is published, Sermorelin remains under its current classification. The announcement indicates intent, not completed regulatory action. Patients and providers should monitor the FDA compounding page for official updates before making treatment decisions.
Reclassification is not the same as FDA approval.
Even if Sermorelin moves to Category 1, it remains an off-label therapeutic that requires physician supervision. Category 1 means it can be compounded under section 503A — it does not confer approved-drug status.