DSCSA deadline sets one-year alarm call for enforcement

From today, pharma manufacturers should be applying the new serialized product identifier detailed in the DSCSA legislation to their US packs.

The FDA has already said that it won’t enforce that requirement just yet – although it remains in force - but the date serves as a reminder that companies now have only one year to get fully compliant and it remains a legal imperative to do so.

All licensed drug products must be serialized to comply with the US Drug Supply Chain Security Act (DSCSA), and with a similar deadline approaching in the EU in February 2019, companies risk major disruption if they do not get their systems in place and validated in the coming months.

It’s worth pointing out that the FDA is also falling behind in the issuance of guidance to help the industry prepare for the DSCSA deadlines as well as other initiatives, such as a long-promised pilot study. A presentation earlier this month by Ilisa Bernstein, deputy director of the FDA’s office of compliance, revealed just how much work still needs to be done on issues such as data exchange and notifications.

Discussing the pilot study plans, Bernstein said that public comments on the use of product identifiers for product tracing and verification – covering the technical capabilities and system attributes needed to utilize them – are still under review. The FDA has scheduled a meeting next month to discuss those technical aspects.

Commenting on the official introduction date, Erik Haeffler, vice president of manufacturing services at contract manufacturer Recipharm, notes that while the FDA has offered a one-year grace period “it can still enforce the regulations at its discretion, meaning companies can still be penalised for failing to comply.”

“In reality, this will probably only happen in cases where something goes wrong, however companies who are not ready to serialise their products today should be working hard to make sure they’re fully compliant come November 2018,” he says.

Manufacturers should now be starting to think about the next phases of the DSCSA, which will eventually mean manufacturers will have to introduce three-tier serialisation and aggregation to fully meet the DSCSA’s mandate in 2023, he continues, adding: “It’s important that companies learn from the mistakes that led to the enforcement delay of the current regulations.”

Contract manufacturers have a particularly complex challenge to tackle due to the variety of products they manufacture and the breadth of customer requirements, says Haeffler.

The consequences of not being ready are serious, according to Carlos Machado, serialization director US at SEA Vision.

“Companies that fail to comply with the regulations risk production downtime and loss of business in key markets. And when you consider the potential impact on patients, the current situation is extremely worrying, with many small and mid-sized companies still struggling to meet the requirements,” he points out.

“For those that are yet to introduce a solution, it is important that they recognize the enormity of the task still at hand, particularly if a lack of resource has delayed their preparations.”

It is also important that companies are aware of the benefits of serialization beyond compliance, for example enabling them to review processes, improve productivity and – potentially at least – gain a competitive edge in the market, says Machado.

“It is also likely that global track and trace requirements will evolve over time. As a result, ensuring that solutions are scalable and flexible to account for this will save resources in the future.”