The compounding pharmacy at the center of a meningitis outbreak that has put 14,000 patients at risk was not following the requirements of its license when it shipped more than 17,000 vials of a contaminated steroid to pain clinics in 23 states, a spokeswoman for the Massachusetts Department of Public Health says.
The company had a license to provide doctors with drugs only on the basis of request. The mass production and shipment of the steroid violated that rule.
All three lots of the contaminated steroid have been recalled and production has been suspended.
“This organization chose to apparently violate the licensing regulations under which they were allowed to operate,” [Madeleine] Biondolillo told reporters in a telephone news conference Thursday.
An FDA spokesman, Deborah Autor, JD, told MedPage Today the agency has legal remedies available, including the ability to seize products and to lay criminal charges, but she did not elaborate further.
A 2006 warning letter to the company, charging it was acting more like a drug manufacturing firm than a compounding pharmacy, elicited assurances that patient safety was being protected and that applicable laws and regulations were being obeyed, Autor said.