US Senate Passes Compounding And Track-And-Trace Bill

After months of negotiating, the US Senate has finally passed legislation that gives the FDA greater oversight of compounding pharmacies and also creates a national system for tracking prescription medicines from factory to pharmacy. The bill, which was already passed by the US House, is designed to bolster the pharmaceutical supply chain, and now goes to President Barack Obama for his signature (here is the bill). As reported previously, the Drug Quality and Security Bill was drafted in the wake of a scandal last year involving a fungal meningitis outbreak that was traced to the New England Compounding Center. So far, there are 751 reported cases, including 64 deaths, and the episode has been called the worst public health crisis in the US in decades (see this). The bill grants an FDA request to create another class of compounding pharmacies (back story). The agency believes that traditional compounders, which mix or alter ingredients for individual patients on an as-needed basis, should be distinguished from ‘non-traditional’ compounders that sell high volumes and ship out of state because these activities may pose a higher risk. “We know more from a barcode on a gallon of milk than we do from a barcode on a bottle of prescription drugs, which could mean the difference between life and death," says US Senator Michael Bennet, a Colorado Democrat, in a statement. "Whether it’s a stronger drug supply chain or better oversight for compounded drugs, this commonsense bill...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs