As Yogi Berra famously said, “it’s deja vu all over again.” Since the Federal Drug Supply Chain Security Act (DSCSA) was enacted in November 2013, most U.S. pharmaceutical supply chain companies and their solutions providers have taken the necessary steps to meet 2015 deadlines for DSCSA requirements. But as we approach the end of the first quarter of 2016, these companies once again face DSCSA deadlines.
In its recently released 2016 U.S. Pharma Traceability Survey, RxTrace offers a snapshot of what industry business leaders are thinking and doing in regard to DSCSA regulations. RxTrace founder Dirk Rogers notes:
“This year’s RxTrace survey results reveal not only how much work the industry has accomplished so far, but also just how much work is left to be done before companies will be ready for the next DSCSA deadlines.”
Download a copy of the 2016 RxTrace U.S. Pharma Traceability Survey, and read more of Dirk’s analysis of this and other pharmaceutical traceability topics at his blog RxTrace.com.
Title II of the DQSA or DSCSA outlines a path to building an electronic system with interoperable capabilities to identify and trace certain prescription drugs distributed in the U.S.
The system will facilitate drug traceability at the individual package level, enabling the exchange of information about where a drug has been in the supply chain. This, in turn, will provide for:
• Verification of the drug-product identifier legitimacy down to the package level
• Detection and notification of illegitimate products in the drug supply chain
• More efficient drug product recalls
About Dirk Rodgers
Dirk Rodgers is a Global Regulatory Strategist, author of the book “The Drug Supply Chain Security Act Explained” and founder of RxTrace.com, where he writes regularly about the intersection between the pharmaceutical supply chain, track-and-trace technology, industry standards and regulatory compliance. An electrical and computer engineer by education, Dirk has worked as a consultant, software architect, automation engineer, and software developer. While at U.S. drug distributor Cardinal Health, Dirk studied the application of serialization and track-and-trace technologies to solve supply chain integrity problems, meet regulatory requirements and improve supply chain efficiencies. He has served on HDMA, NCPDP, EPCglobal, GS1 and GS1 US technical and standards work groups related to ePedigree, track and trace, RFID and barcodes. He also served as co-chair of the GS1 EPCglobal Drug Pedigree Messaging (DPMS) work group and the GS1 Network Centric ePedigree (NCeP) work group.