Drugs made by compounders, including those made at outsourcing facilities, are not FDA-approved. This means that they have not undergone the same premarket review as approved drugs.

Are you willing to take the risk?


Medical Professional

  • Search your compounding pharmacy for warning letters on the FDA’s website.
  • Ask to visit your compounding pharmacy. Has your state board of pharmacy or FDA ever inspected the facility? FDA does NOT necessarily do that, so don’t assume it has. What were the results of any inspection that has taken place?
  • Have a conversation with your Medical Safety/Risk Officer & Legal Team to talk about the patient risks and legal risks of using compounders. What is the plan of action if your compounding pharmacy or outsourcing facility gets a warning letter?


  • Ask your medical professional where they are getting your Rx drug from. If it comes from a compounding pharmacy or outsourcing facility, research that compounder for warning letters or other state or FDA actions.
  • Try seek out non-compounded medications with your prescriber before turning to a compounded drug.
  • Contact your state’s Board of Pharmacy.