Phase I: A Time Challenge
From its enactment in November 2013 to the first-phase deadline in January 2015, the Drug Supply Chain Security Act (DSCSA) didn’t give trading partners much time to prepare. In a short 13 months, wholesale distributors were tasked to:
- Only trade with authorized partners
- Send and receive transaction information, transaction history, and transaction statements (TI/TH/TS)
- Quarantine and investigate suspect drugs
- Notify the FDA and other stakeholders of any illegitimate drugs
- Meet the FDA licensing requirement
Just days before the January 1 2015 deadline, the FDA realized that, “unforeseen complications with the exchange of the required information may result in disruptions in the supply chain, and ultimately could impact patients’ access to needed prescription drugs.” They also recognized “that some manufacturers, wholesale distributors, and repackagers may need additional time.” But that additional time turned out to be just five months – not enough to rethink the solution or the implementation, or change direction in any meaningful manner. It was the FDA’s call to wrap things up. Almost all distributors used those months to soldier through what they had started in order to simply get compliant on time. For many, this meant resorting to work arounds and temporary, patch-job fixes. By May 2015, half of the all distributors were using paper packing slips or emails for product tracing, meeting the 2015 DSCSA requirement but coming up short of the 2017 DSCSA mandate.
Phase II: Complexity Ahead
The DSCSA’s second-phase deadline is almost here. The challenge this time? Meeting complex and stringent requirements.
- By November 2017, distributors:
- must receive electronic product tracing from the manufacturers
- By November 2019, distributors:
- can only trade serialized drug products
- must verify all suspect products using serialized product identifier
- must adopt the requirement for returned resalable products
Wholesale distributors have a lot on their plates. This timetable lays out the entire set of DSCSA requirements.
In phase II, the first requirement calls for distributors to adopt new technologies and do away with paper-based product tracing. Then, in the second requirement, the industry takes a giant leap forward: As manufacturers serialize their drug products, wholesale distributors become supply chain gatekeepers, ensuring all non-serialized drug products stay out of the system. In addition, they also need to verify the drug’s authenticity among the suspect and returned products. It’s that 2019 requirement that is stirring up debate and controversy. That’s because in order for distributors to comply in an effective manner, manufacturers have to go above and beyond what the law requires, introducing aggregation and serialized data exchange.
But, will manufacturers aggregate, and will they pass the aggregation data to the distributors? What are the options for distributors if only some pass on the data, and what if they are in different formats? Those are big questions, and I discussed the wholesale distributor’s approach to these challenges in previous blogs:
- May 4, 2016: Cardinal and AmerisourceBergen Issue Serialization Requirements, Part 1
- May 11, 2016: Cardinal and AmerisourceBergen Issue Serialization Requirements, Part 2
A Time of Challenges and Opportunities for Wholesale Distributors
It’s not only the big three who need to take control of their businesses and their destinies. All distributors need to make critical decisions about their futures – and they need to do it now. When you trade with hundreds of manufacturers and handle thousands of SKUs, there is no simple, one-size-fits-all solution. Bringing the serialized products in and getting the serialized products out – without interrupting the business, and while meeting FDA compliance requirements – is a big job. It requires proper planning, a complex solution architecture, and resources to execute the implementation. That may sound overwhelming, but it doesn’t have to be.
LSPediA: Trusted Serialization Consulting and Proven Solutions
No matter where you are in the process, LSPediA can help you get on track with DSCSA Serialization services. We have a track record of delivering better compliance, better quality, and improved operational efficiency. To find out how you can meet compliance requirements on time, and gain a competitive edge, contact us today.
LSPediA helps pharmaceutical manufacturers and distributors plan, design, and implement processes and solution to meet serialization global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include serialization gap analysis, strategic planning, solution architecture, vendor selection, line execution, CMO management, supplier management, implementation, and more.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.