Fourth Question of the Day October 10, 2013 If one tries to apply the draft federal compounding legislation to various fact patterns it is clear where Congress has gaps? For example, if a compounding pharmacy that does both animal and human compounding opts to be an outsourcing facility for purposes of its sterile human compounding does this mean it has to build a separate area to compound for its animal compounds even though some of those compounded drugs will be identical?

The human side will be inspected and regulated by the FDA and one set of standards.  The animal side will be inspected and regulated by the states and another set of standards.  What about a compounding pharmacy that only does veterinary compounding?  It can compound those same human sterile drugs for animals without any of the new federal legislation applying to it even though there is just as great of risk of human safety from contaminated animal compounds (both food and non food)?  A corporation has three dba pharmacies?  Can some be outsourcing and some not?  What if they are dba different names but all compounded at the same address or location?  What if I want my pharmacies pain compounding cream to be a voluntary but for the rest of my products I want them to remain a "traditional compounding pharmacy"?  Do I just need to set up separate entities dba to skirt the law?  And a pharmacy choosing to remain traditional in no way effects the DEA rules and regulations and criminal controlled substance provisions that must be complied with.  How is that all going to work?  Should DEA have been consulted by Congress especially with regard to the pain prescription problems in America today?