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.