Question Three of the Day, September 27, 2013, What happens when you try to apply the Compounding Quality Act (a part of the Drugs Quality and Security Act) to a situation in the future that is like the NECC outbreak?

Assume NECC does not elect to be an outsourcing facility.  Assume that the FDA nonetheless after receiving information from the states attempts to take enforcement action against NECC.  What do you think NECC's response would be?  We are so glad you showed up to save all these people FDA, come on in, look around, gather evidence, do your job??  I think not.  I think you would get the same response as in the past--FDA  we didn't elect to be under your authority so go away--FDA would then have to go to court and hope for the best! And hope that they could get court action before anyone died.