Explain a compounded formulation.

<!-- -->Naltrexone implantable pellets are a specially compounded, formulation of naltrexone that is patient specific (503A) only after a prescription is written by a medical caregiver who deems that the individual patient is a good candidate for the implantable formulation. Compounding is a common and legal process used by licensed pharmacies to create special formulations and/or combinations of FDA approved drugs based upon a doctor’s prescription. The pharmacies that make each implantable naltrexone pellet must strictly follow state and federal compounding laws.  Naltrexone pellets have been used worldwide for over two decades.  For more information about drug compounding, please visit the FDA’s website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding.<!-- -->