Third Question of the Day February 1, 2014 Is it fair of the federal government (Congress and FDA) to force compounding pharmacists and pharmacies to make decisions about whether to stay traditional compouders or convert to outsourcers when all the guidance and drug lists have no been put in place?

While the argument is that no one has to decide anything right now as far as the DQSA, in reality that is not true--compounding pharmacists who own compounding pharmacies are having to make tough decisions right now about which direction to go.  It is not a matter of just snapping their fingers and filling out paper work. For those good, honest compounders, many factors have to be weighed and balanced.  The factors relate to facilities, drugs to compound, and staff to employee or in some cases lay off, funding and resources, etc.  These are very difficult decisions requiring a lot of careful weighing of these factors.  Guidance needs to be given to those compounders who do both human and animals since a distinction was made by Congress.  They face what appears to be much tougher decisions than those who do solely human compounds or solely veterinary compounds (who aren't affected by DQSA).  The more information the FDA and the states can provide and the sooner they can provide it the better for the good and much needed compounding pharmacists and pharmacies.