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said. When the inspectors informed him that this practice was unac- ceptable, he responded that "he didn't want to waste the money on vials or transfilling the vials if the…lot failed testing." According to the inspection reports, Mr. Cadden later said using aluminum foil "wasn't his usual practice" and then bizarrely denied that the beaker actually contained any betamethasone. After a long discussion, the FDA and the state pharmacy board agreed that NECC was a pharmacy, not a manufacturer, and that the board was in the best position to force NECC into compliance. The FDA inspector recommended that the firm "be prohibited from manufacturing until they can demonstrate ability to make product reproducibly and dependably." If NECC didn't improve its practices, the FDA employees predicted there would be "serious health consequences." In 2004, the Massachusetts Pharmacy Board sent NECC a letter offer- ing to place NECC and Mr. Cadden on probation for 3 years for "profes- sional misconduct." NECC would have to take several measures, includ- ing putting in place written policies and procedures and updating them on a quarterly basis. In return, the board would not prosecute Mr. Cadden. NECC's attorney responded, claiming that NECC had already insti- tuted all the board requirements with the help of "a national expert in Aseptic Compounding." That was a testament, the attorney wrote, to NECC's and Mr. Cadden's "commitment to quality assurance and regu- latory compliance." The NECC facilities had passed 3 board inspec- tions. NECC was now licensed in 44 states. Accepting the disciplinary action would be "potentially fatal" to the business because of the "col- lateral consequences" to the other 43 licenses. The members of the pharmacy board voted unanimously to deny NECC's proposal for lenient treatment. Ultimately, though, for reasons not publicly known, the board then decided to back down, placing NECC on a suspended 1 4 4 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J U L Y 2 0 1 6