Tirzepatide (compounded)
Compounded copies of the approved dual GIP/GLP-1 receptor agonist tirzepatide — permitted during the shortage era, now in enforcement wind-down.
Also encountered as: Tirzepatide · GLP-1 copy · class: GLP-1 / metabolic
Where it actually stands
Compounded copies of this approved drug were permitted while FDA's shortage designation held. The shortage resolved, the enforcement-discretion window closed, and FDA moved: warning letters to 30 telehealth companies in a single February batch over compounded GLP-1 marketing. FDA's own alert page further documents fraudulent compounded product carrying false label information — including labels naming licensed pharmacies that did not compound the product — and notes most compounders are not required to report adverse events.
The record
Primary sources
FDA warning letters, Feb 20 2026 · FDA: “FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss” (fda.gov) · Q3 2026 brief verification. Full citation list available on request.