Feds look to clamp down on compounding

Sunday, July 6, 2003

July 7, 2003

WASHINGTON - Two U.S. senators are demanding a deeper examination of the growing industry of pharmacy compounding, according to the Kansas City Star.

U.S. Sens. Kit Bond of Missouri and Pat Roberts of Kansas, both Republicans, last month sought an investigation in to compounding by the General Accounting Office, the Star reported.

In addition, the senators won Senate approval to have an advisory committee spend a year studying compounded drugs, including whether they are safe and necessary. The committee's creation was included in the Senate’s Medicare reform bill.

Bond and Roberts also announced they are planning congressional hearings on compounding in September. Bond, who will lead those hearings, is working with his staff to develop a witness list.

The senators’ interest in compounding was prompted by the Robert Courtney drug dilution case. Courtney pleaded guilty last year to diluting cancer drugs he compounded for nearly a decade and is serving a 30-year sentence. Authorities estimate that as many as 4,200 patients were affected by the worst drug dilution scheme in modern U.S. history.

The compounding industry remains largely unregulated by the federal government. Oversight falls to state pharmacy boards, which rarely test compounded drugs for safety or effectiveness. Such lack of oversight enabled Courtney to dilute cancer drugs he mixed.

Any new rules governing compounding would also cover respiratory medications, say HME sources.

Federal and state regulators are uncertain how many prescriptions are compounded annually, but they say the number is growing.