Changes, if any, won’t come before next year
Tennessee Board of Pharmacy
Tennessee regulators took initial steps Wednesday toward possibly tightening oversight of compounding pharmacies, but any changes — as well as disciplinary action against the Massachusetts firm whose moldy medicine has been linked to a deadly meningitis outbreak — won’t come until next year.
The Tennessee Board of Pharmacy will create a task force to study the issue and make short-term and long-term recommendations. The board also will survey the state’s 1,900 pharmacies to find out the scale and scope of compounding, or the practice of making custom medications for individual patients.
More definitive steps, if any, won’t come until after the task force reports back to the board, which isn’t scheduled to meet again until January and has a history of being a gentle disciplinarian of compounding pharmacies.
“The board has to work within the current laws, so they did what they could do in an immediate fashion,” said Andrew Holt, its executive director.
The task force, whose members will include pharmacy board members, staff and pharmacists, will study all aspects of compounding, including regulations. Its focus will be on compounding of sterile medications, or those that are injected, administered intravenously or given in the eye.
Authorities believe a steroid solution prepared by New England Compounding Center in Framingham, Mass., was contaminated with fungus and injected into as many as 14,000 people nationwide to relieve pain. More than 460 have become infected, primarily with meningitis, and 32 have died — including 13 in Tennessee.
Among those stricken is the brother-in-law of Charles “Buddy” Stephens, the pharmacy board’s vice president. He said he will recuse himself from any board action concerning NECC.
“I think that the people from NECC and the people who produced these products, I think they should be held accountable,” he told reporters during a meeting break. “It is, in my opinion, a criminal offense.”
The board already has voided the licenses of NECC and Barry Cadden, its pharmacist-in-charge and co-owner, but planned to levy fines as well. Those plans were put on hold after the board learned they have hired Nashville attorney Bill West to contest any penalties. West did not return a call seeking comment Wednesday.
A hearing probably will be held at the board’s January meeting, said Jane Young, the state Department of Health’s general counsel.
The survey and task force were among several suggestions Holt offered for the board’s consideration in the outbreak’s aftermath. Others include tweaking license applications and inspection reports to include more information about sterile compounding activity, and creating an electronic tracking system.
The board will send representatives to a Dec. 19 meeting being organized by the U.S. Food and Drug Administration to discuss compounding regulations. Holt also said U.S. Sen. Lamar Alexander invited him to answer questions that will be entered into a Senate hearing today on the outbreak.