This afternoon HR 3204 The Drug Quality and Security Act passed the US Senate via voice vote and is on its way to the President's desk. With the challenges of implementing the Affordable Care Act and its provisions, Obama is expected to quickly sign this bill into law. As soon as this law is enacted, the Food and Drug Administration will be looking to the Food Drug and Cosmetic Act (FDCA) Section 503A to impose action against compounding pharmacies not in compliance with this statute. Throughout the history of this bill, ITL Consulting has been tracking and discussing the possible outcomes of this bill with pharmacy owners, pharmacists and law makers. Provided below are links to main discussion points in examining where pharmacy compounding is headed.
Will my pharmacy be targeted by the FDA?
What exactly does the FDCA mean for pharmacy compounding?
What are some potential ramifications of this bill?
Will access for patients be affected by this bill?