Do Compounded Medications Require FDA Approval?

The FDA approval process is 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.

About PCCA

PCCA is an independent compounding pharmacy's complete resource for fine chemicals, devices, equipment, training & support.