Congress has enacted legislation to regulate compounding pharmacies. Just over a year ago many cases of fungal meningitis alarmed public health authorities around the country. Most cases were linked to spinal injections of contaminated steroid medicines produced by the New England Compounding Center. Eventually, 64 people died and over 700 required treatment.
Compounding pharmacies in other states were also found to be turning out contaminated products. Over the last year there have been drug recalls from nearly two dozen compounding pharmacies.
Now Congress has passed a new bill that gives the FDA authority to inspect high-volume compounding facilities. This is a voluntary process, however, so only pharmacies that register with the FDA will be subjected to inspections. There is hope that hospitals, clinics and doctors’ offices will only order medications from FDA-inspected facilities and thereby improve the overall manufacturing standards of such products.
