Happy New Year! It is natural for each of us to look back on the year and see where we did well and where we stumbled and also to assess how the past year might shape the one to come. Here is a little overview of events that shaped the FDA landscape this year:

Legislation and FDA Authority - Occasionally FDA gets new regulatory authorities as a result of legislation passed by Congress. Despite the fact that this Congress has not produced as much legislation as others have, the Congress did pass and the President did sign legislation – the Drug Quality and Security Act – that gives the agency new authorities in regulating compounding pharmacies. The action came after several high-profile recalls during the course of the year that resulted in Congressional hearings, FDA testimony and consequential legislation. An overview of the compounding issue events can be found at the blog web site tab on Compounding.

The Law of Compounding Medications And Drugs