By Elise Viebeck - 07/02/13 05:04 PM EDT
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 HarkinTom HarkinGrassley challenger no stranger to defying odds Clinton ally stands between Sanders and chairmanship dream Do candidates care about our health or just how much it costs? MORE (D-Iowa) and Sens. Pat RobertsPat RobertsSenate panel approves pension rescue for coal miners Congress set for Saudi showdown with Obama GOP pressures Kerry on Russia's use of Iranian airbase MORE (R-Kan.) and Al FrankenAl FrankenOvernight Cybersecurity: FBI probes possible hack of Dems' phones | Trump's '400-pound hacker' | Pressure builds on Yahoo | Poll trolls run wild Dems slam Yahoo CEO over delay in acknowledging hack Senators challenge status quo on Saudi arms sales MORE (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.