A longtime goal of the FDA is for the industry to put in place a national system that would allow it to follow a drug product from manufacturer to pharmacy. After years of back-and-forth with the industry about how that would be done, it is about to get started.
A piece of legislation that contains provisions for a 10-year rollout of a national track-and-trace system as well as tighter rules on compounding pharmacies looks like it will get finished up this week, Bloomberg reports. The House passed the bill in September right before the 16-day government shutdown. The Senate, which also supports it, has been passing provisions this week that set it up for final approval and then to go to the president.
The industry has dragged its feet for some time, seeing the hurdles that must be overcome to link a complex supply chain of individual players from manufacturers to logistics companies, to warehousers and transit firms, each having to make the investments required so that they can account up the line for a single drug unit at any point along its route. But California has a state law in place that would require some of the same things, and it is set to take effect in 2015. Unable to defeat it, the industry got very serious this year about getting legislation passed that would give it more time to prepare. The federal law will override California's statute.
The Drug Quality and Security Act sets out the steps that must happen in that 10-year timeline to lead to a national track-and-trace system. The provisions of the bill require drugmakers in four years to provide electronic transactions information and histories. They will also have to begin providing unique identifiers on each package so the products can eventually be tracked electronically through every step from plant to truck or plane and warehouses along the route until they reach their final destination.
The bill actually tackles two priorities of the FDA. It also clarifies the agency's powers over drug compounders and sets up a voluntary program for those compounders who choose to be regulated by the FDA. The compounding-pharmacy provisions were written after last year's fatal outbreak of fungal meningitis, which the FDA tracked to drugs made by the New England Compounding Center (NECC), a compounder that has since closed. The outbreak killed 64 people and infected more than 750 in 20 states.
- here's the Bloomberg story
10-year timeline set for unit-level drug tracking
Industry ready to resurrect track and trace negotiations
Legislation defines when FDA can take action against compounders
Call for track and trace resurrected in face of more counterfeits