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Track-and-Trace: Drug Quality and Security Act of 2013
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The issue of biopharmaceutical supply chain security and integrity has been the subject of much debate, especially regarding the incursion of counterfeit drugs into the healthcare delivery system. Congress and others have called for legislation creating a uniform, national track-and-trace or drug pedigree system.
The enactment of the Drug Quality and Security Act (DQSA) 0f 2013 (sponsored by Rep. Fred Upton (R-MI) brings a national track-and-trace system for medicines and new laws governing compounding pharmacies. It requires standard numerical identifiers (SNIs) to be added to individual packs and (non-mixed) cases within four years, and electronic tracing of production through the supply chain mandated within 10 years. It strengthens licensure requirements for wholesale distributors and third-party logistics providers, and asks the FDA to maintain a database of wholesalers that will be available to the public through its website. Also, the bill supersedes all state-based electronic pedigree (ePedigree) measures, rendering them obsolete and resetting the timelines for serialisation compliance.
MichBio supports the establishment of a robust, scalable, and uniform national system for drug product traceability that would standardize efforts nationwide and provide immediate measure to increase supply chain security and patient safety. We thank Rep. Upton and Congress for enacting the DQSA.

Related Resources

What You Need to Know About the Drug Quality and Security Act
BIO Praises National Track Trace Legislation
Drug Quality and Security Act (pdf)

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