Legislation seeks more oversight of pharmacy compounding

The U.S. Senate this week will begin work on a law that would provide new oversight of the practice of pharmacy compounding.

If enacted, the law would be the first far-reaching piece of federal legislation to reform compounding since Kansas City pharmacist Robert Courtney shocked the nation more than a decade ago with his admission that he had diluted thousands of doses of chemotherapy medication.

Compounding is a traditional part of pharmacy practice in which pharmacists mix medications from scratch but without having to meet the same exacting safety and quality standards that large drug manufacturers must follow.

The legislation, written by Kansas Sen. Pat Roberts and three of his Senate colleagues, would clarify for the first time the roles of federal and state agencies in regulating compounding.

Though Roberts has worked steadily to strengthen compounding laws over the last 10 years, his new legislation received special urgency last fall when a spinal meningitis outbreak killed dozens and sickened hundreds more. The outbreak was traced to contaminated steroid injections prepared by the New England Compounding Center in Massachusetts.

Roberts, a Republican, said Friday that he is encouraged by the willingness he has seen in colleagues on both sides of the aisle to work on this issue again.

It really is unfortunate that 53 people have to die and 700 get sick before we have the will to do this, Roberts said. We havent given up. Were persevering, and were doing it the right way. We just have to get it done.

The Kansas City Star first laid out concerns about the safety of compounded medications in a three-part series in 2002. Responding to that report and Courtneys admissions, senators organized their initial hearing on compounding practices in 2003. But industry opposition blocked any significant changes.

The compounding industry remains mostly regulated by a patchwork of state boards of pharmacy, which often do not have the capacity to oversee large operations that compound thousands of doses of sterile medications and then ship them across the country.

The U.S. Food and Drug Administration argues that it is hamstrung by a lack of clear jurisdiction.

More here:
Legislation seeks more oversight of pharmacy compounding