A Few Things the Senate Needs to Consider With Regard to Pharmaceutical Compounding Quality and Accountability Act- Before It Comes Before the Senate for A Vote

July 2, 2013

by Sue Tuck Richmond

There are a few a things the United States Senate needs to consider as it debates the Pharmaceutical Compounding Quality and Accountability Act.  First, pharmacy is pharmacy in the states.  Veterinary pharmacy is not separate for the most part.  While a few states such as Virginia and Texas have specific veterinary regulations addressing compounding that apply to veterinarians, these regulations do not apply to pharmacies or pharmacists.  The state board of pharmacy rules and regulations apply to compounding.  I have posed the questioned of whether pharmacy should be pharmacy and whether veterinary pharmacy should be separated out, but right now it is is not in the states.  In light of this treatment in the states, it makes little sense for federal legislation to apply only to human compounding.  Nor is it clear that the current draft as        written would only apply to human compounding.  

Second, I have also discussed this issue:  the do not compound list.  The legislation should require that a committee or a commission.  The committee or commission should be made up of not only FDA officials but also knowledgeable compounding pharmacists, pharmaceutical representatives, doctors, veterinarians, marketing representatives, and consumers who meet, discuss and recommend a do not compound list to Congress who must approve it much like it does the United States Sentencing Guidelines factors.  This will prevent the FDA from having complete authority over what cannot be compounded.