States appear to be cracking down on compounding pharmacies nationwide, in the wake of a meningitis outbreak linked to contaminated steroid injections that were mixed by a Massachusetts pharmacy and shipped to medical providers throughout the United States.
Compounding pharmacies are designed to supply local health care facilities with tailor-made drugs for specific patients. However, the New England Compounding Center (NECC), which recalled more than 17,000 vials of steroid injections believed to be contaminated with fungus, employed sales representatives throughout the United States and distributed medications to facilities in at least 23 states.
According to the latest update on the meningitis outbreak linked to the NECC compounding pharmacy, the U.S. Centers for Disease Control and Prevention (CDC) indicates that illnesses have been confirmed in 19 different states, including 363 cases of fungal meningitis, 7 joint infections and 28 deaths.
State and federal regulators have faced substantial criticism for lax enforcement of quality control standards at compounding pharmacies and for failing to take steps that may have prevented the meningitis outbreak.
Enforcement Against Other Compounding Pharmacies
A long history of problems at NECC have now been identified, including failure to maintain a controlled clean room to reduce the risk of microbial contamination during the processing of drugs and a failure to ensure that medications were safe before they were distributed.
Since the outbreak, NECC has surrendered its license and now faces a criminal investigation in Massachusetts, potential federal charges and a number of product liability and class action lawsuits over the recalled steroid injections.
Other compounding pharmacies are now starting to see stronger enforcement actions by state regulatory agencies, which many believe are long-overdue in the industry.
This week, Florida announced that it has suspended the license of a Rejuvi Pharmaceuticals, a compounding pharmacy in Boca Raton. Inspectors say the pharmacy violated a number of statutes, including rules on cleaniliness and how drugs were dispensed, both of which problems identified at NECC that are believed to be contributing factors to the current fungal meningitis outbreak.
Florida officials say that they reviewed prior inspections of Rejuvi Pharmaceuticals and found that many of the violations had been noted before, but no action had been taken and the compounding pharmacy had failed to address them. This is similar to reports and FDA documents that showed that NECC had problems dating back at least eight years.
In Massachusetts, state regulators announced that a second compounding pharmacy, called Infusion Resource, agreed to surrender its license this week. It did so after it was found to have a center where it distributed intravenous medication, which is a violation of state law that requires facilities to obtain a clinic license to do so. There were also issues that could have compromised the sterility of its products, state officials said.