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Struggling to comply with DSCSA for prescription drugs? FedEx TranSmart® can help!

January 7, 2015

Many regulations and initiatives worldwide aim at further securing and controlling the complex supply chain of healthcare shipments. The US Drug Supply Chain Security Act (DSCSA), also known as Title II of the Drug Quality and Security Act (DQSA), was signed into law on November 27th, 2013. It represents a staggered approach towards serialization, and electronic track-and-trace for human prescription drugs in finished dosage form. Eventually each individual package of prescription drugs will have a unique number, and the journey of each package will be documented, from manufacturing site to final patient. Transaction information, transaction history and transaction statement (TI/TH/TS) need to be captured, preferably in electronic format, whenever there is a change in ownership in the supply chain. DSCSA regulation applies to manufacturers and dispensers (such as pharmacies) via wholesale distributors and distribution centers. DSCSA makes it mandatory for buyers and sellers to pass on transactional data starting on January 1st, 2015 (dispensers have until July 1st, 2015 to comply). Collected data need to be maintained for at least six years.

FedEx Express and FedEx Ground move millions of packages each day. Despite the volume, scans applied to each shipment during transit can be easily accessed online via tracking numbers. Are you struggling to replicate the FedEx tracking system to your supply chain? FedEx can help healthcare companies track their products. 

DSCSA replaces and expands the US Prescription Drug Marketing Act (PDMA) of 1987, which originally inspired FedEx to use its expertise to develop a solution called FedEx TranSmart® for prescription samples received by dispensers. FedEx TranSmart provides a secure validated electronic database to retrieve shipping records for the past seven years. Records include proof of delivery signatures and acknowledgement of contents. FedEx TranSmart has been instrumental at enabling healthcare shippers to meet regulatory requirements and pass Food and Drug Administration (FDA) audits around PDMA. Features are now updated for you to satisfy transactional DSCSA requirements.

 


Christelle Laot

Technical Fellow

Dr. Christelle Laot joined FedEx Express in 2007, and is currently Technical Fellow in the FedEx healthcare industry vertical. In this role, she provides direction and raises awareness around trends, transportation regulatory frameworks and shipping solutions. Prior to her work with FedEx, Dr. Laot held managerial positions in R&D, innovation and strategy at Bayer in Germany for about six years.

Dr. Laot obtained PhD and MS in Chemical Engineering from Virginia Tech (USA), a Diplôme d’Ingénieur from UTC Compiègne (France), as well as an MBA from HEC Montreal (Canada).

View all Christelle Laot’s blog posts

Comments

    Charles Anthony says:

    I recognize that FedEx TranSmart is designed to meet the sample requirements of the PDMA, but what additional functionality has been added to meet the DSCSA serialization requirements?

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