US House Passes Compounding And Supply Chain Safety Bill

A bill hailed as a big step toward improving the safety of the pharmaceutical supply chain passed the US House over the weekend and the US Senate is widely expected to pass the legislation, which is designed to bolster FDA oversight of compounding pharmacies and also institute a nationwide system for tracking shipments of prescription drugs. “This legislation would address two important issues affecting the quality and security of America’s drug supply,” says Health Subcommittee chairman Joe Pitts, a Pennsylvania Republican, in a statement. “First, the bill would protect traditional pharmacies and clarify laws related to human drug compounding in response to last year’s nationwide meningitis outbreak… Second, the bill would strengthen the prescription drug supply chain in order to protect American families against counterfeit drugs (here is the bill). The passage was hailed by various industry groups and some consumer advocates after protracted debate. Called the Drug Quality and Security Act, the bill emerges nearly a year after an outbreak of fungal meningitis that was traced to a Massachusetts compounder (back story). So far, there have been 750 cases, including 64 deaths, in what has been called the worst public health crisis in the US in decades (more here). The episode led to a furious debate over the ability of the FDA to oversee pharmacy compounders.  As we noted previously, the agency has repeatedly argued that conflicting court rulings limited its autho...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs