Breaking News: Important! Must Read!! Draft of House Legislation Comments Needed by June 20, 2013

By Karla L. Palmer –

On Friday, June 14, 2013, Congressman Morgan Griffith (R-VA) released a draft billaddressing compounding of human drugs.  The draft primarily was influenced by the revised draft guidance document the Food and Drug Administration (“FDA”) was prepared to release in the fall of 2012, prior to the New England Compounding Center (“NECC”) incident.  This bill does not define a “compounding pharmacy” or create a “compounding manufacturer” category, unlike the pending Senate Health, Education, Labor and Pensions Committee (“HELP”) legislation (S. 959).  Congressman Griffith’s draft proposal retains two categories – pharmacies and manufacturers – and clarifies how FDA would distinguish compounding pharmacies from drug manufacturers.  The issue of linking compounding to identified patients is a key feature of the bill.  

continue reading summary and comments from FDA Law blog here