GOP senator urges vote on drug compounding bill

{mosads}”The health committee worked on and the unanimously passed a bill to help prevent such a crisis from happening again, and the legislation should be called up for a vote as soon as possible.”

The death toll from the fungal meningitis outbreak officially rose to 61 on Tuesday.

Nearly 750 others have been sickened by the infections, which were caused by tainted steroid shots produced last year by the now-shuttered New England Compounding Center (NECC).

Compounding pharmacies generally fit into one of two categories — traditional compounders, which produce custom medications on a prescription-by-prescription basis, and nontraditional compounders, which produce drugs in large quantities to ship across state lines.

Currently, traditional compounding pharmacies are regulated by state boards, while their nontraditional counterparts fall into a legal gray area that gives both state regulators and the FDA a role in their oversight.

The NECC, a nontraditional compounder, was cited several times for violating safety standards but did not improve conditions at its manufacturing site.

The resulting deaths and illnesses sparked debate in Congress about how to improve oversight of pharmacy compounding. Another recent outbreak, linked to a compounder in Tennessee, has drawn more attention to the issue.

Alexander’s bill, introduced with HELP Committee Chairman Tom Harkin (D-Iowa) and Sens. Pat Roberts (R-Kan.) and Al Franken (D-Minn.), would empower the FDA to oversee nontraditional compounders while preserving state boards’ role in regulating traditional compounding pharmacies.

The HELP Committee unanimously approved the legislation on May 22, but Senate leaders have not indicated when the bill might come to the floor.

House lawmakers are asking similar questions about compounding oversight, but in key committees, the parties disagree about giving the FDA new regulatory powers.