Sermorelin
FDA’s 2013 Geref withdrawal determination is not approval of every compounded sermorelin claim.
Historical product context is specific.
In a March 4, 2013 Federal Register notice, FDA determined that the named Geref sermorelin acetate injection products were not withdrawn from sale for reasons of safety or effectiveness. The notice concerns those specific products and is historical regulatory context.
FDA said the determination would allow approval of abbreviated applications if other legal and regulatory requirements were met. It is not evidence that every currently marketed or compounded sermorelin product has been approved.
Do not translate a withdrawal determination into an anti-aging, body-composition or general wellness endorsement. This page gives no dosing or buying advice and does not verify current commercial availability.
Interpretation is limited to the source linked above. Independent medical review pending.