The individual ingredients within the pellets are FDA-approved, and the distribution of these pellets is regulated by the FDA. However, the pellet insertion procedure itself is not FDAapproved. It's common for physicians to prescribe medications or therapies for uses not explicitly approved by the FDA (off-label) if they believe them to be safe and effective for their patients. The reason bio-identical hormones (compounded drugs) are not FDA-approved is due to their individualized dosing nature.