Get news updates from WGBH
Thu November 15, 2012
Compounding Pharmacy Regulations Debated in Washington
A second day of testimony took place in Washington today on the deadly meningitis outbreak that resulted from contaminated drugs produced in a Massachusetts compounding pharmacy. 32 people have died, another 460 are sick by contaminated steroid shots.
A Senate panel considered new restrictions on compounding pharmacies, which currently operate under various state and federal regulations. But David Miller, CEO of the International Academy of Compounding Pharmacists told lawmakers that current regulations are adequate, and called the New England Compounding Center in Framingham an “illegal drug manufacturer."
“There are questionable overlaps in the regulation of compounding pharmacy. But let me reiterate there is no question who has the authority to immediately shut down an illegal prescription drug manufacturer. That rests with the FDA," Miller said.
Compounding pharmacies mix ingredients to produce medication for a specific patient based on a prescription. Dr. Lauren Smith, Interim Commissioner of the Massachusetts Department of Public Health, said the state takes some responsibility.
“The report was clear, it indicated with sufficient detail that NECC was clearly operating outside of Massachusetts pharmacy laws. We, the board certainly knew of NECC at that time and that it had issues so it should have been a red flag that was followed up on and it wasn’t," Smith said.
The New England Compounding Center has been shut down, but state and federal lawmakers continue to seek accountability for the deadly meningitis outbreak.