Friday, May 10, 2013
Question of the Day May 10, 2013 With the FDA's acknowledgement that it does not know the extent of the compounding problem, and proposed federal legislation that only extends to "compounding manufacturers"
how do states ensure that another NECC doesn't occur again if the federal legislation is passed. Is it simply a matter of the states enforcing the rules and regulations already in place? Aren't more specialized, specifically trained inspectors needed in the states? Aren't more inspectors at both the state and federal level needed? One way that federal drug prosecution cases work is that a task force is created and state and local officers are cross deputized as federal officers for criminal prosecutions. Is this something that would work for compounding cases? Why or why not? Could it possibly work for the administrative, civil cases also? How about the reverse, where all compounding inspections require an FDA officer to be present, even though the state would take the lead in the inspection and in disciplining the pharmacy and pharmacists? Would it be possible to model the federal legislation more like the federal controlled substance laws and have joint task forces who work on these cases?