By Bill Fletcher, managing partner, Pharma Logic Solutions

Track and TraceTwo years ago, the House of Representatives signed into law a bill aimed at preventing the growing issue of pharmaceutical counterfeiting with mandates to improve serialization in the tracking and tracing of pharmaceuticals products. The Drug Supply Chain Security Act (DSCSA), or Title II under the Drug Quality & Security Act, transforms the way pharmaceuticals are regulated in the United States by placing greater responsibility on pharmaceutical trading partners’ documentation process. By 2017, pharmaceutical manufacturers will be required to serialize all products.

As of 2015, DSCSA requires drug manufacturers from manufacturers, through wholesalers and distributors and to the hospitals, pharmacies or other point of dispensing to provide detailed transaction documents (TDs) of every sale of prescription controlled drugs. Under the new law, all entities in the supply chain including wholesalers, which are now required to attain state level licensing, must be registered with the federal government. The onus is on each entity selling prescription products to certify that the companies they are selling to are also properly licensed, and sellers and buyers must retain the TDs for six years to aid in investigations.

TDs provide a path of legitimacy for pharmaceutical products, helping regulators and manufacturers identify and weed out counterfeits. However, it is important to remember that DSCSA cannot completely eradicate counterfeiting. Unlike regulations in some European countries, US track-and-trace regulations are not centralized. Without a central repository of serial numbers, pharmaceutical manufacturers — and ultimately, patients — can still be vulnerable to counterfeiting.

Tasked with the responsibility of verifying the licenses of their suppliers – as well as their customers – and providing documentation for products during every step of the supply chain, pharmaceutical manufacturers can become overwhelmed by the scale of due diligence. However, implementing simplified and effective track-and-trace technologies and practices does not have to be complicated. Streamlined compliance depends on the clear understanding of these requirements, the challenges they pose and the holes they leave in supply chain security and protection against counterfeiters.


Learn More at the Pharma EXPO Conference Program EPSON MFP imageAt this year’s Pharma EXPO (Las Vegas Convention Center; Sept. 28-30), Bill Fletcher tackles the challenges pharmaceutical manufacturers face in navigating compliance and success amid DSCSA. His session, “Serialization and Track & Trace: From Theory to Practical Application Success Including Global Trends,”will focus on the advantages and disadvantages of a centralized regulation model and how the United States’ current system compares to the centralized model on an international trade level. Fletcher will also cover solutions for implementing the new processes and teach companies how to comply with the new regulations in order to maintain efficiency without disruption.

The session falls on Tuesday, Sept. 29, as part of the day-long Compliance Trends track of the Pharma EXPO Conference Program, curated by the International Society for Pharmaceutical Engineering (ISPE).

Pharma EXPO, co-located with PACK EXPO Las Vegas, is co-produced by PMMI, The Association for Packaging and Packaging Technologies and ISPE.  Learn more and register at