While there may not be new DSCSA regulations going live in 2021, that doesn’t mean manufacturers can take a break from thinking about their DSCSA and serialization strategy this year. The 2023 requirements still loom ahead.

In fact, though technical challenges, operational hurdles, and COVID-19 all spurred a delay in the wholesaler saleable returns requirements, the FDA has noted on several occasions that they do not intend to have any further enforcement delays leading up to 2023, including the 2023 requirements themselves.

Manufacturers will need to not only take stock of their current procedures and identify where they might not be fully compliant, but also invest time and resources into laying out the roadmap for ’23 compliancy.

The Biggest DSCSA Compliancy Challenges in 2021

Yes, enforcement of the wholesaler saleable returns requirement has been pushed to 2023, but the industry and wholesalers are still moving forward with turning on this functionality in advance of 2023. That means it is still the manufacturer’s obligation to respond to these requests within 24 hours – or sooner. Wholesalers often can’t wait a full day and expect a response in real-time. Over the next two years, manufacturers must stay up-to-date with wholesalers in order to understand whether to continue investing in VRS or move toward sending serialized data with sales shipments or perhaps a combination of both approaches.

Apart from the initial timeline delays, COVID-19 has impacted another important component of DSCSA preparation: organization. Simply getting organized and on the same page with partners is a challenge when everyone is remote. The CMO’s and packagers are still only letting critical personnel in the facilities, resulting in communication struggles and longer lead times to get projects completed.

Perhaps the most challenging task for manufacturers in 2021 will be deciding which investments to make. With the industry still uncertain about DSCSA best practices, choosing which processes and tactics to invest in will be tricky. Manufacturers will need to seek the counsel of a trusted advisor to avoid any costly missteps.

The Industry’s Response

Though not a challenge exclusively for manufacturers, simply coming to a consensus on the industry blueprint for DSCSA compliance will be a difficult, yet vital, task in 2021. As we navigate the challenges of COVID-19 and approach the next DSCSA compliancy date, we anticipate that industry task force groups will continue to meet and establish industry best practices. Expect increased activity from the Partnership for DSCSA Governance (PDG), a public/private partnership with the FDA, as they lay out how the industry needs to handle some of the toughest issues. These conversations will be vital for creating an industry consensus, which is why Two Labs has joined this group to provide technical consultation as well as represent our clients in these important discussions.

How Manufacturers Can Be Proactive

Many manufacturers have November 2023 circled on their calendars as the due date to meet requirements for passing serialization data downstream to customers. However, what this deadline really means is that manufacturers need to have this capability tested and in production prior to January 2023.  This will be due to demands from downstream customers and the associated lead time it will take to build up “inventory of data” to be prepared to send the unit level data all the way to the dispenser.

Throughout 2021 and 2022, it will be important for manufacturers to assess their options and ensure they are optimally set-up for this increased level of data exchange. This might mean aligning with new providers, but it definitely means more implementation work and connections with distribution (3PL) partners. Not only does proactive implementation give manufacturers time to understand and iron out any exception handling processes that may be needed come November 2023, but it also prevents them from being “too late” and missing out on the appropriate resources aligned to do the work.

DSCSA will bring many new capabilities to the pharmaceutical industry, but the transition process can seem daunting. At Two Labs, we’re here to help lighten the load. Click below to chat with one of our experts who can help make sure your transition to DSCSA compliance is as easy as possible.

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