Wednesday, October 31, 2012

States Crack Down on Compound Pharmacies Amid Meningitis Outbreak

By: Irvin Jackson | Published: October 31st, 2012
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.

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