DSCSA one month countdown to the enforcement deadline


Leaders from across the pharmaceutical sector discuss the industry’s readiness and what companies should be thinking about in the final month before and beyond the deadline

Leaders from across the pharmaceutical sector discuss the industry’s readiness and what companies should be thinking about in the final month before and beyond the deadline.

Brian Daleiden, vice president of industry marketing at TraceLink

"In TraceLink’s Global Drug Supply, Safety and Traceability Survey, a major disparity between perceptions of readiness and actual progress was found among business leaders preparing for DSCSA. Not one of the respondents who felt ‘very ready’ for serialisation had actually taken all the fundamental steps towards serialisation readiness."

"The sense is that most of the market will be ready for the upcoming DSCSA deadline although there is a chance that some organisations, most notably pharmaceutical companies working with CMOs that are not fully prepared, will struggle to meet the deadline.

The challenges associated with being ‘serialisation-ready’ have prevented many businesses from looking ahead and preparing for what is next. Since many companies have been laser-focused on becoming serialisation ready by deadline, many have deferred preparing for the next phase of DSCSA, which is when pharmaceutical manufacturers need to have systems in place to meet the impending saleable returns verification requirements imposed on wholesale distributors.

Beyond this, DSCSA regulations will continue to impact all segments of the pharmaceutical supply chain through the year 2023 when fully electronic, interoperable systems for unit-level traceability become a requirement.

Importantly, the November deadline is just the first step toward a digital transformation of the pharmaceutical supply chain. It is vital that businesses begin preparing to leverage the new information created by serialisation to achieve business value.

The digitalisation of the industry will be driven by new technologies generated by pharmaceutical traceability needs, the utilisation of serialisation data and the accessibility to derive value from this data within one platform. Through TraceLink’s digital information-sharing network, fundamental processes that will be transformed through digitalisation include the issuance of supply chain-wide digital recall notifications, the enablement of secure, distributed product verification for supply chain partners, and the launch of patient- centric programs that enable the ultimate consumers of medicines to interact with real-time product information based on the uniquely identifiable products."

Rick Seibert, senior vice president of innovation & technology services at Sharp

"We experienced a large surge of conversion requests for our serialisation packaging services at the beginning of 2017, which was fairly persistent up until the announcement by the FDA that they would delay active enforcement of the DSCSA until November 2018. At that point our conversion workload was still very high but was steady and we were able to convert a large percentage of existing clients.

In recent months, running up to next month’s deadline, there’s been another surge in current client demand, as well as a high number of new clients wanting to convert as soon as possible. There has been a clear recognition that the deadline is closing in."

"For those that are ready, they should turn their attention to realising the opportunities of a serialisation-enabled supply chain. Sharp is already developing programs and services that will allow our clients to use the systems already deployed to create value beyond compliance.

One of our focus areas is around enabling patients to better engage with their treatment and care by providing access to resources and enhanced services via the unique data points on the package created by serialisation."

Staffan Widengran, director corporate projects, Recipharm

"Recipharm has introduced a new standalone serialisation service in advance of the deadline, which will allow pharmaceutical companies to benefit from its serialisation capabilities - Recipharm has serialised around 1.4 million packs for the US market to date. The service includes adding 2D codes and human readable text to pre-packaged medicines. This will ensure that companies that are currently not ready for the deadline have a way to achieve compliance in time, and avoid a gap in production."

Dexter Tjoa, director corporate strategy, Tjoapack

"Outsourcing is an attractive solution for companies that need to ensure compliance, but it is vital that they begin conversations with potential partners as soon as possible. Contract packaging organisations (CPOs) have become a popular alternative to implementing an internal solution over the last year, but – albeit shorter – this solution does present a minimum lead time. The sooner CPOs know about your requirements, the more likely you are to be ready.

And, of course, it doesn’t end there. Companies that are ready for the November deadline, should start turning their attention to ensuring they are well-prepared for aggregation requirements, come the 2023 deadline."

Daniel Tedham, managing director of Wasdell Manufacturing, a division of the Wasdell Group

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"Better prepared companies should be looking look to make the most of their serialisation investment by exploring the additional opportunities presented by this increased level of supply chain visibility. Aggregation capabilities should be prioritised as they will be phased in as three-tier parent-child relationships between barcodes become a requirement of DSCSA in 2023. Wasdell has invested in aggregation as part of its serialisation service to ensure it could meet this requirement and any future regulations."