Political Quotes

“it has now been about 1 year since the fungal meningitis outbreak last fall associated with the tainted sterile compounded drugs from the New England Compounding Center. This week on the floor of the Senate, we have a bill that is, in many senses, Congress's response to the lack of policy clarity that many have suggested failed to prevent that tragedy. As I have watched the Senators and their staff who have been working on this bill over the past several months, I applaud the bipartisan manner they have used in creating legislation that could help prevent similar tragedies in the future. I am planning on voting for this legislation because I do think Congress needs to legislate. The courts have not been clear. However, I want to note that, despite the strong bipartisan collaboration, this legislation leaves some regulatory oversight concerns outstanding that I want to comment on and make clear today. There has been a lot of concern that by reaffirming section 503(a) of the Food, Drug and Cosmetic Act, office use of compounded drugs is not recognized as permissible compounding activity. Therefore, I want to make clear that this legislation does not change current State law or authority over the dispensing or distribution of medications by pharmacists, compounded or manufactured, for a prescriber's administration to or treatment of a patient within their practice.…”