The Patrick administration Thursday unveiled new emergency regulations to more tightly oversee compounding pharamacies like the Framingham facility linked to the national fungal meningitis outbreak.
The new rules, approved by the Massachusetts Board of Registration in Pharmacy, will for the first time allow the state to track the volume and distribution of drugs made by compounding pharmacies to determine whether they are operating more like a manufacturing facility subject to licensing by the US Food and Drug Administration.
Penalties are included for pharmacies that fail to comply with rules and regulations, and the rules give the pharmacy board the ability to more easily shut down operations of a compounding pharmacy and quarantine its products. The regulations also require pharmacies to report when they are the subject of an investigation by another state or federal authority.
“The emergency regulations that the board of pharmacy approved this morning allow us to begin to close the gap a little bit in Massachusetts, by requiring any of the pharmacies that do sterile compounding to report to us on the quantity of the products they’re making and where they’re sending it ... so we can catch earlier those that look like they’re manufacturing more than they’re actually compounding,” Dr. JudyAnn Bigby, state secretary of health and human services, told reporters Thursday afternoon after a visit to Tufts Medical Center.
Governor Deval Patrick, who joined Bigby, said, “The compounding industry has evolved, and in some ways it has outgrown the current regulatory framework, not just the state but the federal regulatory framework.”
Massachusetts Congressman Ed Markey unveiled federal legislation Thursday to address what he called a “regulatory black hole” currently governing these pharmacies by giving the FDA new oversight authority.
At least 28 people have died and 377 have been sickened after receiving injections of a contaminated steroid medication linked to the now-closed New England Compounding Center in Framingham.
“No one should live in fear that their medicine is unsafe, and these actions at the state and federal level will help ensure we’re at the forefront of efforts to protect public health,” interim state public health commissioner Dr. Lauren Smith said in a statement.
The Department of Public Health also announced Thursday that Christian A. Hartman, a specialist in pharmacy practice and patient safety, would chair a new Special Commission that will study potential changes to laws and regulations to fill the regulatory gray area between state and federal oversight.
Hartman is founder and president of the American Society of Medication Safety Officers, and previously served as medication safety officer at UMass Memorial Health System in Worcester and as a pharmacist at Brigham and Women’s Hospital in Boston, according to the Patrick administration.
State law requires compounders to have a patient prescription for each dose of medication produced, but officials have said New England Compounding was operating like a manufacturer, mass producing medications in violation of its state license. The FDA licenses drug manufacturers.
The new 10-member state commission will make its recommendations to the Patrick administration by Dec. 31, the statement said.