On Monday, the Senate gave final approval to H.R. 3204, the Drug Quality and Security Act. The legislation will give the Food and Drug Administration (FDA) more power to regulate so-called “compounding pharmacies” — facilities where custom drugs are mixed to fill prescriptions or outsource to hospitals on a large scale.
The legislation is in direct response to last year’s deadly meningitis outbreak stemming from a tainted batch of steroids mixed at a New England-area compounder found to have unsanitary workplace conditions. The drugs infected hundreds of Americans, and ended up killing 64 people.
The FDA argued that lax federal oversight and mixed lines of authority between states and the federal government made it difficult to regulate such pharmacies in the outbreak’s aftermath. The legislation passed on Monday allows compounders that ship their drugs across state lines to re-register as “outsourcing facilities” that are subject to the same quality control rules and regulatory oversight as more traditional pharmacies. It would also create a national electronic tracking system for drugs created at these facilities.
While public health advocates lauded the bill’s passage, FDA officials expressed disappointment that the legislation didn’t go even further. Compounding facilities will not be forced to register with the FDA under the law, and pharmacies that forgo the stricter requirements can still mix drugs on a small-scale or prescription-by-prescription basis.
Still, advocates believe that most major compounders will end up registering with the FDA thanks to market pressures, since hospitals are far more likely to buy drugs from facilities whose products are officially sanctioned by the federal agency.