Court Throws Out 1 New England Compounding Case

The Massachusetts federal court has dismissed an indictment charging two former New England Compounding Center employees with felony counts of dispensing drugs into interstate commerce without a valid prescription. Attorney Andrew Hull (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that the controversial aspect of the indictment is that the two were not pharmacists, but actually were in charge of the final check of prescription drug packages for accuracy of name, address, and contents.

The government argued that the two workers had to have known that the prescriptions were phony because the patient names were so unlikely — celebrities, athletes, and fictional characters. It said that their incidental role in checking the packages for the phony prescriptions made them as guilty as the pharmacists who dispensed the drugs without a valid prescription.

However, Hull writes, the court held that the Federal Food, Drug, and Cosmetic Act (FFDCA) does not define “dispensing” and said that the word should be given its meaning in common parlance within the statutory context. Given that, the court said, the act did not provide fair notice to the defendants that their activities could be considered dispensing.

“Absent the constitutional due process that fair notice provides to defendants informing them that their activities are covered under a criminal statute, the court ruled that the indictment, as it pertained to [the two], failed,” Hull explains. “Specifically, the court held that because the defendants’ conduct was only ‘incidental’ to the activity of dispensing, the FFDCA did not provide them with fait notice that their conduct violated the FFDCA.”