New England Compounding Center Pharmacy

New England Compounding Center’s (NECC) history has been the driving force behind the mounting investigations of compounding pharmacies throughout the nation. NECC was a licensed compounding pharmacy that was eventually discovered to be producing and distributing drugs on a much larger scale than that of a traditional compounding pharmacy. It is now known that the pharmacy was successfully avoiding the inspection and regulation that it desperately needed. A severe outbreak caused by NECC’s unsafe practices was ultimately what brought compounding pharmacies to the forefront of governmental and public concerns.

The news of NECC’s involvement in a severe outbreak of infections came in rapidly. On September 26, 2012, NECC voluntarily recalled three lots of steroid injections that were packaged and distributed by the company. The Food and Drug Administration (FDA) announced NECC’s first recall onOctober 6, 2012. The details given in the announcement were scarce, but the recall was broad and included all products that were compounded by and distributed from NECC’sFramingham, Massachusetts facility. The facts eventually surfaced that three lots of NECC steroid injections had been implicated in the 2012 outbreak of fungal meningitis. As of March 25, 2013, that outbreak ultimately caused 720 infectionsand resulted in 51 deaths.

On October 26, 2012, the FDA announced that it had observed and confirmed the contamination of NECC’s products.  NECC was not maintaining sterile conditions in its clean room at its facility.  Because a pharmacy’s “clean room” is supposed to provide an environment that ensures no surface contamination and controls airborne particles, NECC’s inability to properly maintain its clean room increased the risk of product contamination. Though the FDA noted that NECC’s inspection report was not yet complete, some of NECC’s products wereconfirmed to be contaminated; therefore, it followed that none of NECC’s products could be deemed safe.

Thus, in November, the investigation of NECC by the FDA, Centers for Disease Control (CDC) and Massachusetts State Health Department was ongoing. During the investigation, the FDA and CDC had identified fungus in products administered to an approximated 14,000 patients. Bacteria wasalso found in some NECC products, though the implications of that bacteria were not yet known. The FDA advised that health care physicians follow-up with patients who had been given injections of products supplied by NECC. On November 13, 2012, the FDA announced that NECC had decided to recall all of its products and shut-down its facilities.

On December 12, 2012, the FDA announced its NECC lab testing results.  It found that bacterial and fungal contamination was confirmed in unopened vials of various solutions distributed by NECC. Some of the bacterial contaminants were human pathogens. Some of the fungal contaminants were known to cause disease. It was clear that NECC had been engaging in unsafe sanitization practices.

NECC filed for Chapter 11 Bankruptcy on December 21, 2012 and vowed to establish a victims’ compensation fund to efficiently handle the hundreds of lawsuits that were, and still are, being brought against the company. However, the Bankruptcy records showed that the company paid its four founding members over $16 million in profits from December, 2011 up to the time it declared bankruptcy, even after the company had shut down production. These numbers indicated that the company was much larger than traditional compounding pharmacies were intended to be.

To add, the effects of NECC’s practices are ongoing.Individuals who were originally cleared as having no infection are becoming ill even now.  The incubation period of the contaminants found in NECC’s products and administered to patients seems to be much longer than health care professionalsoriginally suspected. Thus, the CDC is encouraging health care providers to keep a watchful eye over patients that received the contaminated drugs.

As the current system is set-up, the FDA regulates drug manufacturers, and the state boards of pharmacies regulatecompounding pharmacies like NECC. However, many of these compounding pharmacies are producing and distributing drugs on a massive scale — a scale equivalent to that of drug manufacturers. Though authorities are still attempting to figure out how best to regulate these massive compounding pharmacy operations, such action is now being taken seriously. The horrific events surrounding the fungal meningitis outbreak, and the discovery of the unsafe conditions at NECC, have prompted the creation of stricter regulations for the 7,000+ compounding pharmacies now operating in the United States.