At the Forefront of Compliance—The Drug Supply Chain Security Act

The Challenge

In an effort to combat counterfeit medicines in the global marketplace, the Federal Drug Administration (FDA) introduced the Drug Supply Chain Security Act (DSCSA) in November of 2013. This plan would eventually track medicines down to the vial with a unique numerical identifier, securing the pharmaceutical supply chain unlike ever before.

The FDA set a phased implementation approach for full compliance over the next decade, ultimately extending that deadline several times. The final deadline for manufacturers and repackagers was set for May 2025.

Because something of this scale had never been attempted before, there wasn’t a blueprint or ‘best practices guide’ to follow. Pharmaceutical manufacturers and solution providers were tasked with creating a solution to the mandate from scratch.

The Solution

Developing a new solution, especially one of this scale, comes with its own set of unique challenges.

Third-party logistics provider MD Logistics is used to building solutions to their clients’ unique challenges. So much so that they have made it a standard part of business practices—cross-functional teams collaborating together to bring to bear a customized solution for their clients’ toughest challenges.

When the team at MD Logistics was approached by one of their largest pharmaceutical clients in 2017 about developing a serialized solution that would make their supply chain compliant with the DSCSA mandate, the MDL team was eager to begin the process.

Not knowing how others within the supply chain, i.e. wholesalers, would interpret the law and without a blueprint or best practices guide—MD Logistics started conversations with their client by mapping their current process.

Having an understanding of what the current process looked like made it easier to picture how serialization could fit into existing operations.

Mapping the process also made it clear what adjustments needed to be made to current operations to accommodate capturing the sheer volumes of data that now needed to be recorded and passed along with the product throughout the supply chain.

Developing a serialization solution required a highly collaborative environment, not only among internal teams, but also among the client and external business vendors.

Because the DSCSA mandate was a new initiative within the industry, the team at MD Logistics had to work with their external warehouse management system (WMS) provider to develop a WMS with the serialization configuration needed to accommodate all of the necessary requirements.

MD Logistics initial pharmaceutical client was fully compliant in 2017, with all other serialized clients compliant by 2022. Throughout the process of guiding clients to full compliance, lessons were learned, and adaptations were made to achieve a solution which previously didn’t exist within the industry.

Without a clear guide, collaboration and ongoing communication led by the MD Logistics team, proved to be the secret to developing a truly customized solution for their client, thus leading their supply chain in DSCSA compliance.

---

To learn more:
[email protected]
317-838-8900
www.mdlogistics.com