This episode for 503Bs has to do with compliance. I know this is a big issue that has a lot of complexity and is a constant source of training and conversation.  Since compliance is so integral to the operation of a compounding pharmacy I was having lots of discussions on staff training, procedures, sops etc.  and it got me thinking, what is the best way to achieve full compliance. Of course that is a pipe dream and can never fully happen but after conversations with several industry leaders it appears that the best way to start is to begin by introducing business decisions into the regulatory planning. I spoke with Karla Palmer about this and she led a talk with Travis Leah from QuVa and Kimberly Kieffer from Empower about the challenges of meeting both regulatory and business objectives in the outsourcing facility space.  In this series we have two episodes. In this one we are considering the question of why -- in the compounding space in particular -- how compliance and important compliance decisions must be fully integrated into the business activities of the company and how to go about integrating compliance procedures into business activities?  Our next episode will address the interplay between state and federal regulatory issues, and how important that interplay becomes in a facility’s business decisions.

Support the show