Guest Column | December 28, 2021

EPCIS Implementation In Biopharma: 4 Survey Takeaways & Next Steps For DSCSA Compliance

By Michael Rowe, Two Labs

Vaccine COVID 19

With the Nov. 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. Sponsored by a variety of industry stakeholders (including Two Labs), the EPCIS Implementation Benchmarking Survey dives into the readiness of manufacturers, distributors, and 3PLs, as well as the barriers they may be facing as they attempt to implement data transfers that are required to meet the upcoming DSCSA deadlines.

For those that are not as familiar with EPCIS (Electronic Product Code Information Services), it is a data standard developed by GS1 (a nonprofit standards company) that allows companies to store and transmit information regarding product movement and status. Specifically updated to meet DSCSA requirements, EPCIS version 1.2 for U.S. healthcare has become the industry standard to pass serialized product data amongst trading partners. It is worth noting that distributors and other industry groups promote, and in some cases mandate, the use of EPCIS to send the serialized data, which will be required by DSCSA to be passed with each transaction (sale) of product by Nov. 27, 2023. 

This article shares the four major takeaways of the survey results and concludes with recommendations for where to go from here.

1. We May See A Push For Manufacturers To Self-Service.

Roughly 60 percent of manufacturers are not yet sending data downstream to distributors. Imagine over 300 manufacturers attempting to connect with technology partners, distributors, 3PLs, etc., all in a condensed, last-minute time frame. That’s a serious bottleneck scenario.

In response, as we approach the DSCSA deadline, we may see technology providers push manufacturers to be more self-service during the testing phase. They simply won’t have the bandwidth to accommodate the wave of manufacturers rushing to get compliant. For manufacturers that rely heavily on their providers, a delay in EPCIS implementation means gambling whether they’ll be live in time.

2. Manufacturers May Miss Out On Vital Testing.

Sharing the EPCIS serialized data downstream in the supply chain in conjunction with the physical movement of product is new for the pharmaceutical industry, which means we don’t know what we don’t know. Only when the data starts flowing will we truly see – and be able to troubleshoot – the errors. The longer a manufacturer waits to implement EPCIS, the shorter the grace period for testing and correcting the transfer of data.

For errors that are easy to correct, like transcribing the wrong address, it may not take long to adjust. However, labor-intensive problems that involve upstream fixes with your supply chain, such as how the data is created during the production, have a significantly longer lead time. Manufacturers that build in space for trial and error will have a leg up when DSCSA compliance becomes mandatory in 2023. Keep in mind, if the product is received without the data, the product cannot be further distributed, which, of course, will negatively impact patients and a manufacturer’s bottom line.

3. Smaller Manufacturers Aren’t Sure Where To Start.

Though the HDA survey doesn’t specifically segment responses by manufacturer size, we can infer the DSCSA compliance readiness of smaller manufacturers based on a few key pieces of data:

  • A typical 3PL currently is working to connect an average 67 manufacturer clients. On average, a 3PL has only 10 successful connections today.
  • Manufacturers cited lack of guidance (31 percent), adequacy of employee resources or availability (29 percent), and the ability to dedicate IT staff to testing and implementation (22 percent) as key obstacles to EPCIS implementation.

This tells us that of the manufacturers that are already connected and ready for data exchange, the majority are likely to be larger manufacturers with dedicated EPCIS implementation teams and IT staff in order to self-manage.

Smaller manufacturers with no dedicated IT team typically rely on their 3PL or serialization vendor, but with the impending bottleneck, this is likely to cause serious delays. To ensure they don’t fall behind, these manufacturers should be looking to engage a pharma services partner to get the ball rolling ASAP.

4. Distributors Are Asking For Data A Year In Advance — For Good Reason.

Starting November 2023, any product in inventory that has no data associated with it legally cannot be sold. The key phrase here is “any product in inventory,” which includes products sent before the official deadline.

For example, imagine a manufacturer sold a product to a downstream wholesaler in May of 2023 but doesn’t complete their data transfer until August. In late November, the wholesaler goes to ship the product, but because it was received before the data was live in the system, the product can’t be shipped. We don’t currently know what the procedure will be to account for these products, but we do know they simply will not reach the patient. This is a serious implication and exactly why distributors are requiring all data to be in production a full year ahead of 2023.

Manufacturers must consider the time it takes for their products to move through the supply chain when developing their strategy for EPCIS implementation. This is especially true of specialty or low-volume manufacturers that don’t go through inventory quickly.    

Where Do We Go From Here?

The HDA survey shows the industry isn’t quite as prepared for interoperability as stakeholders would have hoped, but the goal is still within reach. For manufacturers still needing to kickstart implementation on what it takes to become DSCSA compliant, these are some of the most immediate next steps:

  • Audit your data: Don’t assume your data is flowing properly. Do an assessment to make sure you’re getting the data you need and in a format that can be shared. Start by understanding where it’s coming from and where it’s going. Then, compare it against where it has to go and how it will flow. Is your serialization data currently being aggregated (which is the data hierarchy of unit serial numbers that are embedded into a case and pallet)? Understand your inventory positions either in your own warehouse or 3PL and assess how much product is at risk of not being distributed because the serialized data hasn’t “moved” with the product. Finally, determine who you need to connect to downstream and the preferred method of connection.
  • Budget: After you assess the data you have, the gaps you need to fill, and how you plan to connect, you then need to figure out what it’s going to cost. Don’t delay this step. Now is a good time to set your budgets to carry out the work needed for next year. 
  • Develop a testing project plan: As mentioned above, end-to-end testing will be critical for manufacturers as they implement EPCIS. Build in time to develop and execute a thorough test plan, making sure you understand how you’ll prove success and solve for errors.
  • Plan for the exceptions: There’s no denying exceptions to the standards will happen. Think through the resourcing and management of these scenarios in advance and understand the best roles, responsibilities, and workflows for handling these within your organization.
  • Monitor: Though the FDA has said the November 2023 deadline will not be moving, requirements and best practices are ever evolving. Stay engaged in industry forums and monitor for important updates.

About The Author:

Michael Rowe is the serialization services manager at Two Labs, a pharma consultancy/services company in Columbus, OH. He is well known for his DSCSA expertise and has spoken at several industry conferences and events, and he is a Lean Six Sigma Black Belt. Prior to Two Labs, he spent time with a large wholesale distributor as a manager of their Track & Trace program, advising all of their divisions, suppliers, and customers on DSCSA requirements.