In September of 2012, a meningitis outbreak occurred that would go on to infect over 800 people, killing 76. The investigation by the CDC and the FDA eventually found that the source was contaminated steroid injections from the New England Compounding Center in Framingham, Massachusetts.

While the compounding center was able to combine, mix, or alter ingredients to fill certain prescriptions, they were not allowed to act as a drug manufacturer - which they had been doing anyway. Instead of completing the needs of individual prescriptions, they were creating drugs for broad use. As a result, 14 NECC employees were charged with criminal offenses, including the president of the company. Many believe that the NECC was aware that their drugs were either mislabeled, unsanitary, or contaminated, but continued to send them out for use.

From this outbreak came the Drug Quality and Security Act, which enabled the FDA to have more control in the process of making and distributing compounding drugs.