Regulatory status and access

Approved, narrow, prohibited in sport, and increasingly compounded

Tesamorelin sits in an unusual legal space. It is a fully FDA-approved drug, but only for one narrow indication, it is prohibited in sport, and it is increasingly offered as a compounded product for off-label use, each status carrying different rules.

This unit traces the FDA history, maps the status across contexts, explains why compounded tesamorelin is regulatorily distinct from branded Egrifta, covers the anti-doping ban, and lands on an honest bottom line.