WBUR’s Martha Bebinger reports:
Federal officials say as many as 14,000 people may have been exposed to tainted medication from the New England Compounding Center.
State and federal regulators say they are still investigating the exact cause of the outbreak. But the FDA’s Deborah Autor says regulators would like more clarity about state and federal authority over such pharmacies.
State regulators say it appears that the New England Compounding Center violated state law by supplying large amounts of medicines without an individual prescription.
Sources close to the investigation says NECC followed state laws.
The Massachusetts Department of Public Health says New England Compounding Center was licensed to mix specialized medications based on individual prescriptions. So selling vials of steriods in bulk to hospitals across the country, where 169 patients are now ill from tainted injections, was not allowed, says Madeleine Biondolillo, with the DPH.
“This organization chose to…apparently violate the licensing requirements under which they were allowed to operate,” she said.
Sources close to the investigation say the company is expected to claim that it did not produce prescriptions in bulk for Massachusetts, but that its state license did not prohibit bulk shipments outside of Massachusetts.