Regulatory questions
The combination discussion sits beside an older medical history. These are the status questions that deserve an answer of their own.
Was sermorelin FDA-approved?
Yes. The FDA’s historical determination records the diagnostic formulation approved in 1990 and the therapeutic formulations approved in 1997. The treatment indication concerned children with idiopathic growth hormone deficiency and growth failure. The diagnostic use tested the pituitary’s capacity to release growth hormone.
I think this history deserves more precision than a bare “FDA-approved” badge. It attaches to particular finished products and indications. The same history supplies no adult anti-aging indication and no approval for a modern combination.
The 2008 withdrawal
The sponsor requested withdrawal of both formulations in 2008. The 2013 FDA determination found that they had not been withdrawn for reasons of safety or effectiveness; the withdrawal was commercial. No FDA-approved finished sermorelin drug is currently marketed in the United States.
The loss of commercial GHRH availability also affected testing. A 2009 clinical review discussed the implications for adult growth hormone deficiency diagnosis and alternative stimulation tests. That consequence is easy to miss when the whole history is reduced to a discontinued product.
How does prescription compounding fit?
The present record describes sermorelin preparation through state-licensed 503A pharmacies and 503B outsourcing facilities under prescription and the applicable compounding rules. The January 2025 interim 503A policy provides the framework for bulk substances; the FDA guidance document sets out that policy.
A compounded sermorelin preparation has no FDA approval. FDA does not review it for safety, efficacy or quality before patient use. I regard access, approval and a demonstrated benefit as separate questions: a preparation being available cannot settle its clinical value for a particular goal. An individual assessment by a U.S.-licensed clinician determines whether prescribing is appropriate and may result in no prescription. For U.S. patients, the state of residence and the particular treatment determine the possible options.
An online request also leaves the formulation, pharmacy requirements and the person’s health to be assessed. A former approval cannot perform that assessment.
What does WADA say?
Sermorelin falls under Section S2 of the WADA Prohibited List and is prohibited at all times for athletes subject to the Code. Use without a granted Therapeutic Use Exemption carries anti-doping consequences. Prescription status and sport permission are separate matters.
The mass-spectrometry method paper includes sermorelin and related GHRH analogs among peptide analytes screened in urine. Analytical detection answers whether a substance or its metabolites can be identified. It contributes no evidence of a worthwhile training benefit.