Compounding pharmacies legislation passes the Senate
The U.S. Senate passed a bill Monday afternoon that will increase federal oversight of compounding pharmacies that custom mix medications in bulk. The measure comes in response to last year's deadly meningitis outbreak that killed 64 people including a Salem man.
The Senate approved the bill Monday by voice vote. The legislation would also create a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and later through electronic codes.
U.S. Senator Tim Kaine says the deadly outbreak of fungal meningitis exposed a weakness in the system. In a phone interview Monday afternoon, Kaine told WDBJ7, "this was obviously a significant kind of loophole in the law that allowed these compounders to exist with deadly consequence... There has to be some form of regulation."
The fungal meningitis was traced to tainted medicine that came from a Massachusetts compounding pharmacy, New England Compounding Center (NECC,) which has since closed, where inspectors found mold, standing water and other unsterile conditions. The company shipped more than 17,600 doses of implicated steroid injections to 23 states, according to the Associated Press.
47-year-old Douglas Wingate from Salem, died from fungal meningitis last fall, according to the medical examiner's report, after getting a steroid injection at Insight Imaging in Roanoke.
More than 700 others were sickened, including a 15-year-old Cave Spring High School sophomore who was hospitalized for 12 days from fungal meningitis. His father, Ben Foutz said his son is doing better but is still not 100 percent.
Republican Ninth District Congressman Morgan Griffith co-sponsored the bill which is called the Drug Quality and Security Act. It passed the House on September 28th and Monday afternoon passed the Senate in a voice vote.
It's meant to clarify the authority of state and federal regulators such as the Food and Drug Administration in an effort to prevent a national public health crisis like the 2012 fungal meningitis outbreak, Griffith said in the statement via Twitter.
“Though work remains to be done, the Drug Quality and Security Act will clarify who is responsible for overseeing facilities that produce sterile drugs," said Congressman Griffith. "This bill, if in effect prior to last year, would have prevented NECC's improper conduct from going undetected by the appropriate agencies."
Some have criticized the legislation saying it does not go far enough and believe states must also pass legislation to more closely monitor compounding pharmacies. Massachusetts, where NECC was located, has passed laws since the meningitis outbreak.
The bill now heads to President Barack Obama's desk where he's expected to sign it.
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