A Call for FDA Regulation of Compounding Pharmacies

As I predicted on this blog on Oct. 9, a recent outbreak of fungal meningitis has led to a renewed call for FDA regulatory authority over the burgeoning drug compounding industry. As you may recall, the outbreak was traced to bad batches of a steroid that had been packaged by a drug compounding company in Massachusetts. So far 461 people have been infected and 32 persons have died, according to the CDC.

Drug compounding used to be done by neighborhood pharmacies on a limited basis, primarily for local doctors and patients. Traditionally, pharmacies are regulated by the individual states. But with the rise of the Internet and of large health care systems and hospital chains, compounding pharmacies have become highly specialized, high-volume facilities that sell their products nationwide. And yet like all pharmacies, compounding facilities are still regulated primarily by the pharmacy boards of individual states.

This week the commissioner of the FDA appeared before a congressional committee to ask for increased authority to monitor and regulate compounding pharmacies. According to the commissioner, compounding pharmacies are not even required to give the FDA access to their books, for example. Surprisingly (or perhaps not so surprisingly!) the congressional committee seems to be split along party lines, with republicans arguing that the FDA already has enough authority to regulate compounding pharmacies and democrats arguing that the FDA should be given more regulatory authority. We’ll be watching this one.