— Are pharmacies required to identify if they produce large quantities of compounded drugs?
— Are pharmacies required to have a patient-specific prescription before producing a compounded drug?
— Are pharmacies required to meet federal guidelines for sterile compounding?
The meningitis outbreak has reignited long-standing questions about who should be responsible for overseeing large compounding pharmacies.
All pharmacies, including compounding pharmacies, have long been regulated by state pharmacy boards, many of which date back to the 19th century. The 1938 law which created the FDA excluded compounding pharmacies and gave the agency power to regulate drug manufacturers.
But in the 1990s, FDA regulators began to more closely scrutinize compounding pharmacies, as some grew into large businesses that resembled manufacturers. However, efforts by FDA to regulate pharmacies have been repeatedly challenged in court.
At congressional hearings last week, the head of the FDA asked lawmakers to draft new laws that would give the agency direct authority over large compounders.