Reps. Rosa DeLauro, D-CT, and Nita Lowey, D-NY, introduced a bill on Wednesday that would give the FDA greater authority to oversee compounding pharmacies. The bill comes in the aftermath of a meningitis outbreak linked to a Massachusetts compounding pharmacy that has left three dozen dead and regulators saying they don’t have sufficient authority to prevent future outbreaks. The Supporting Access to Formulated and Effective Compounded Drugs Act would require compounding pharmacies to register with FDA, establish a national database of such pharmacies, and task FDA with setting their production standards, among other provisions.
10
Dec 2012