Who ensures that drugs made by compounding pharmacies are safe?

The FDA traditionally regulates drug manufacturers. But states regulate pharmacies. Even so, three government agencies regulate compounding pharmacies:

  • State boards of pharmacy ensure that pharmacies follow state regulations for pharmacy practice
  • The FDA regulates “the integrity of the drugs” and the active pharmaceutical ingredients from which they are made.
  • The Drug Enforcement Administration regulates compounding pharmacies’ handling of controlled substances.