Serialization requirements have arrived, introducing new challenges and opportunities
More than two years into lot-level requirements and just months from the first serialization deadline, the industry’s full focus is on the next phase of Drug Supply Chain and Security Act (DSCSA) requirements. With serialized product about to enter the market, every supply chain segment that has a defined role under DSCSA—pharmaceutical manufacturers, repackagers, wholesale distributors, and hospitals and pharmacies—is preparing and anticipating exactly what challenges—and opportunities beyond compliance--come next for them. The industry learned under lot-level mandates that trade partner requirements had as much of an impact as regulatory ones, and that will continue to be the case under serialization.
Despite the 12-month enforcement delay announced by the FDA in June 2017, the law is still in effect for pharma companies come November 2017, and they should be reaching the end of their preparations. Pharma companies have had to integrate with CMO partners; make decisions about aggregation, which is not a regulatory requirement but a trade partner priority; address more frequent validation and how to achieve it with the lowest cost to staff and budget resources; and—most importantly—determine out how they will manage the massive data volumes and data exchange complexities introduced by the law without compromising operational speed.
Hospitals and pharmacies
At the other end of the supply chain, healthcare providers discovered that addressing lot-level requirements took a heavy toll on their operational efficiency. Dispensers--as they are referred to under DSCSA—took varying approaches towards compliance, with more than 4,200 dispensing locations partnering with TraceLink to take it off of their plates. Their serialization deadline isn’t until 2020, but healthcare providers will be able to capitalize on serialized data long before that to better manage inventory, product recalls, and more.
With serialized product entering the market, wholesalers will need to manage hybrid inventory for an extended period as they receive some physical product with serialized data, and some without. They will have to address the verification requirements driven by saleable returns, and determine operational flows to manage both aggregated and non-aggregated product. At the same time, they must prepare for their own serialization deadline in November 2019.
When their serialization deadline arrives in November 2018, repackagers will need to be able to generate serial numbers for their repackaged medicines, and have a way to maintain the relationship between the parent and repurposed products.
Relying on the market leader for compliance, and all the value beyond
The TraceLink Life Sciences Cloud, with more than 257,000 supply chain members, has processed over 265 million Transaction Histories under DSCSA, and commissioned more than 380 million serial numbers worldwide. With U.S. requirements calling for unprecedented connectivity between companies, the network enables you to interoperate with all of the businesses on it, seamlessly exchanging data and collaborating on key business processes. We accept any data type and translate into a canonical format, neutralizing one of the key challenges of DSCSA. We also have mechanisms in place to manage exception handling and trade partner demands, both of which have proven to be a significant challenge in the compliance landscape.