Traceability Bill Passes U.S. Senate

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Traceability Bill Passes U.S. Senate

Approximately one week ago, H.R. 3204, also known as the Drug Quality and Security Act or DQSA, passed in the U.S. Senate by a unanimous vote. Ultimately the track-and-trace bill will result in new laws on a national level governing medicines in regards to compounding pharmacies. At the time of news reports, the bill was ready to go to the President's desk for his signature. Essentially, medicines utilizing serial numbers on individual packs and non-mixed cases will be required to have the federal traceability system in place within four years of adoption of the legislation. Companies manufacturing these medicines will also be required to implement electronic tracing of production through the supply chain within 10 years of the legislation being adopted. H.R. 3204 renders the ePedigree measures proposed by California obsolete; serialization compliance timelines will now have to be reset. In his address to the floor, Senator Lamar Alexander (R-TN), Committee ranking member of HELP (Health, Education, Labor, and Pensions) stated that over time, prescriptions will be traceable from the manufacturer to the pharmacy. In the U.S., there are about four billion prescriptions written on an annual basis; Alexander said that it will take several years to fully implement the track-and-trace bill. We all remember the 2012 meningitis outbreak linked to NECC. The facility, which is now closed, was a compounding pharmacy whose drugs led to the deaths of more than 60 individuals. The new legislation will boost oversight of these pharmacies, giving the FDA increased power to oversee outsourcing or large-volume compounders. Tom Harkin, HELP Committee Chairman, said that the passage of the track-and-trace bill is a testament to what can be achieved in Congress when both parties work together, and that it is a monumental step toward drug safety. Regardless of whether consumers obtain their prescription medications at a pharmacy, hospital, or their doctor's office, it is critical they have confidence that the drugs they take are safe. With the passage of H.R. 3204 consumers will gain confidence in the pharmaceutical industry in the coming years. As leaders in industrial traceability solutions, Markem-Imaje is always on top of industry news, including not only pharmaceutical but food, personal care, electronics, and postal industries as well. Trust our solutions for all of your traceability, coding, and printing needs!

January 10, 2014
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