Compounding pharmacies have been making headlines a lot in recent months, almost always with terrible news.
The most devastating stories related to the New England Compounding Center, which is blamed for a meningitis outbreak that caused more than 50 deaths and another 700+ people to suffer injuries across 19 different states. However, the NECC is not the only compounding pharmacy to be in trouble for failing to live up to its obligations to patients.
Our Boston injury lawyers know that efforts are being made to change how compounding pharmacies are regulated because many pharmacies are not currently following best practices and safety guidelines. Unfortunately, a new report this month shows that tougher regulations and better enforcement cannot come soon enough.
Compounding Pharmacies Shut Down for Violations
According to the Boston Globe, two compounding pharmacies were shut down in mid-August of this year. The pharmacies were located in Quincy and in Norwood and were shut down after a surprise state inspection.
The inspection of one of the pharmacies that was shut down had been conducted on the second of April. According to a media relations manager for the Massachusetts Department of Public Health, the inspectors found that the property was non-compliant with a myriad of regulations. This included board regulations such as a requirement that prescriptions be verified and requiring specific handling for expired medications and sterile compounding.
Following the inspection, the Board of Registration in Pharmacy ordered the pharmacy to halt its operations. However, despite the notice to the pharmacy, it continued to operate, violating the cease and desist order from the court. A cease and desist was subsequently sent to a sister company for assisting in violating regulations. The Board of Registration also suspended the licenses of the compounding pharmacies and of the managers of the pharmacies.
This August, the hearings on the cease-and-desist orders and on the license suspension began. The outcome of the hearing could result in the compounding pharmacies being forced to make changes to ensure that they are providing reasonable protection to patients.
The inspections that led to the hearings are part of an enhanced oversight program put into place following the disaster at the New England Compounding Center that prompted the fatal meningitis outbreak.
The need for these inspections has become quite clear, though both state and federal regulators did little enough to protect the public before the high-profile outbreaks began. As the Boston Globe reports, there were 37 compounding pharmacies in the state of Massachusetts that were inspected by state inspectors since the enhanced oversight rules went into effect. Only four of the compounding pharmacies that were inspected were actually able to pass the inspection. This means that another dangerous meningitis outbreak or similar outbreak could easily have occurred at any one of these pharmacies.
With tougher enforcement of laws and regulations, hopefully the compounding pharmacies will begin to step up and provide reasonable health and safety assurances. The unannounced inspections will reportedly continue for an indefinite period, which could also help to ensure that compounding pharmacies take extra steps to ensure safety.
If you or a loved one was injured, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.
More Blog Entries
Meningitis Victims Sue Sister Company of New England Compounding Pharmacy, Boston Personal Injury Attorney Blog, July 29, 2013.