File Type:	Name:	Publish Date:	Size:
	Track and Trace Solutions for the Pharmaceutical Supply Chain	09/30/2008	353 Kb

Description:	This white paper provides an overview of the capabilities of track-and-trace technologies and applications. This understanding will allow pharmaceutical manufacturers to leverage identification and tracking systems to provide internal benefits, as well as to satisfy regulatory and customer requirements and improve patient safety.
Full Abstract:	Industry concern about counterfeiting, diversion, mishandling, mislabeling, and unintended or mistaken administration of prescription drugs is mounting at an unprecedented pace. Stakeholders at all junctures of the pharmaceutical supply chain – from point of production to point of care – recognize the vital importance of traceability. Not only does traceability contribute to product safety and security, but it can also support manufacturers’ efforts to improve productivity and profitability. Interest in, and adoption of, automated track-and-trace systems like bar coding and radio frequency identification (RFID) have grown swiftly. This growth was in part driven by regulations. The United States and countries around the globe are reviewing and passing legislation to enhance safety with respect to pharmaceuticals. As the Food and Drug Administration (FDA) set forth in the 1987 Prescription Drug Marketing Act, which went into effect in 2006, bar code identification is required on all unit-dose medication packaging in addition to at least two forms of anti-counterfeiting protection on the packaging. Both houses of the U.S. Congress are examining issues around medication product security and, as of late 2007, 23 states had passed laws requiring an electronic pedigree (e-pedigree). As policy-makers move toward e-pedigree adoption, the industry is progressing closer to that goal. Early experiences with bar coding and RFID across various stakeholder groups demonstrate the opportunities and challenges inherent to securing the pharmaceutical supply chain. This white paper provides an overview of the capabilities of track-and-trace technologies and applications. This understanding will allow pharmaceutical manufacturers to leverage identification and tracking systems to provide internal benefits, as well as to satisfy regulatory and customer requirements and improve patient safety.