My Two Cents: IACP Just Made a Huge Step in the Right Direction Because They Will Now Have Input into Any New Federal Legislation and Regulations

It took David Miller and the International Association of Compounding Pharmacies awhile to jump on board with the new proposed federal legislation that would allow the FDA to oversee and enforce laws and regulations relating to compounders who are considered manufacturers, but this is a step in the right direction and a big step at that.  This is not to say that they or anyone agrees with the FDA taking over completely or part of the regulation of compounders.  What this does say to me is they saw the writing on the wall that some federal legislation is going to be passed into law.  So it is better for them to be on board and have a say in that legislation than to oppose it completely and have no say in the new federal laws and regulations.  With IACP backing the federal legislation that allows FDA limited oversight over compounders this helps prevent there being federal legislation that allows for the FDA to take over all compounding regulation and enforcement.  Now, in my opinion, what needs to happen it that Congress, the FDA, and the groups representing compounders need to come up with a fairly clear list of determining factors as to whether a compounding pharmacies qualifies as a "manufacturer" and is under whatever federal legislation is ultimately passed.  What are some of the factors that should determine if a compounding pharmacy is a manufacturer?