Beginning in 2012, there was a major meningitis outbreak that was attributed to the New England Compounding Center (NECC) in Massachusetts. There were reports of over 800 individuals sickened with meningitis and the death of 76 was reported. This multi-state outbreak of meningitis was investigated by the Centers for Disease Control, the Food and Drug Administration, and the state and local health departments. As a result, it was determined that the outbreak tied to a contaminated steroid injection produced by NECC. This product was manufactured by NECC, which is designated as a Compounding Pharmacy. This type of pharmacy is only authorized to create specific formulations of drugs to meet the needs of individual patients and in response to individual prescriptions. (Anonymous, 2017a)
As a result of this outbreak, many different laws and requirements changed, as well as legal actions taken against employees of NECC. This paper describes some of the changes and legal actions taken.