Do Compounded Medications Require FDA Approval?

The FDA approval process in intended for mass-produced drugs made by large manufacturers. Because compounded medications are personalized for individual patients, it is not possible for each formulation to go through the FDA’s drug approval process, which takes years to complete and is prohibitively expensive, often costing hundreds of millions of dollars.

However, every compounding pharmacy must comply with the regulations set by the State Board of Pharmacy of the state in which the pharmacy is located. Each State Board of Pharmacy has the power to set and enforce regulations for compounding in its state, just as traditional pharmacies are regulated. The ingredients used by compounding pharmacies to make compounds come from FDA-registered and inspected facilities.