Pharmacy at Center of Meningitis Outbreak

The compounding pharmacy at the center of the fungal meningitis outbreak was not following the requirements of its state license, according to a spokeswoman for the Massachusetts Department of Public Health.

The New England Compounding Center in Framingham, Mass., shipped more than 17,000 vials of a steroid -- now implicated in the outbreak -- to pain clinics in 23 states.

But Dr. Madeleine Biondolillo, director of the state's Bureau of Health Care Safety and Quality, said the company was meant to make up drugs only in response to a doctor's prescription for an individual patient.

Read this story on http://www.medpagetoday.com.

"This organization chose to apparently violate the licensing regulations under which they were allowed to operate," Biondolillo told reporters in a telephone news conference Thursday.

FDA spokeswoman Dr. Deborah Autor 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.

If the current investigation proves otherwise, she said, " we will hold people accountable appropriately."

She added that the agency has had its eye on the company for some time. "We've been there repeatedly," she said.

Jared Wickerham/Getty Images

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Pharmacy at Center of Meningitis Outbreak