Senate Moves Closer To Passing Pharmacy Compounding Bill

A long-awaited bill designed to provide greater oversight of compounding pharmacies passed a procedural hurdle in the US Senate last night, shortly after the US House of Representatives approved the same measure. As a result, a final Senate vote is expected tomorrow and the law could be ready for President Obama to sign the legislation into law by Friday (here is the bill). The measure, known as the Drug Quality and Security Bill, offers greater authority to the FDA in the wake of a scandal a year ago involving an outbreak of fungal meningitis that was traced to a compounder. So far, there are 751 reported cases, including 64 deaths, that were traced to the New England Compounding Center, and the episode has been called the worst public health crisis in the US in decades (see this). A fierce debate has taken place ever since over the extent to which the FDA has authority to oversee compounders that mimic large-scale drugmakers. The “bipartisan proposal dramatically improves oversight of high-risk drug compounding facilities,” US Senator Tom Harkin, an Iowa Democrat, says in a statement. “The bill also increases the security of the pharmaceutical supply chain by implementing an unprecedented tracing system to track prescription drugs from manufacturing to distribution.” 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...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs