With all the complexities, deadlines and financial implications affixed to the serialization of pharmaceutical products, it’s easy to forget that patient safety is the ultimate reason behind tracing packaged medications throughout the supply chain.
In late June 2017, the U.S. Food and Drug Administration announced a one-year delay in the enforcement of the Drug Supply Chain Security Act’s (DSCSA) requirement for manufacturers to affix or imprint product identifiers to each package or homogenous case of product intended to be introduced into commerce by Nov. 27, 2017.
The enforcement delay to Nov. 26, 2018 does offer some relief for pharmaceutical manufacturers, contract manufacturing organizations (CMOs) and contract packaging organizations (CPOs) struggling to meet the original enforcement deadline. But the fact is that Nov. 27, 2017 remains the deadline for compliance. Companies must continue moving toward the 2023 deadline for full serialization interoperability with track and trace for all partners in the pharmaceutical supply chain.
“The delay is certainly welcome because it takes the pressure off of those who were not likely to have everything in place by this Thanksgiving,” says Dirk Rodgers, Regulatory Strategist for Systech International, founder of RxTrace and author of the book, "The Drug Supply Chain Security Act Explained."
“Solution providers should now have enough time and resources to get everyone in compliance by the end of the delay period,” he continues. “Companies are going to have time to do the proper design and testing now, rather than cram something in just to meet the original deadline.”
The delay also stretches past manufacturers throughout the pharmaceutical supply chain. “Because the one-year delay for manufacturers results in some non-serialized product entering the supply chain after the original November 27, 2017 deadline for manufacturers, FDA was forced to offer some relief to downstream trading partners,” Rodgers explains. “FDA will not enforce the use of the DSCSA product identifier [a.k.a., “serialization”] on those companies in verification requests after their original deadlines. Those were November 27, 2018 for repackagers, 2019 for wholesale distributors, and 2020 for dispensers, but only for product that was actually introduced by the manufacturer during their ‘magical’ one-year delay. That is, the enforcement discretion only extends to product that enters the supply chain from a manufacturer between November 27, 2017 and November 26, 2018.
“Downstream trading partners must have solid evidence of the exact date of introduction, which can be found in the DSCSA transaction history that they are required to receive and retain, or perhaps in other documents. This will make it time-consuming for these members of the supply chain to take advantage of the extension in enforcement,” says Rodgers.
“The FDA’s decision to delay enforcement by one year doesn’t change Reed-Lane’s plans to be ready to serialize by the end of November 2017,” says David Manis, Sales & Marketing Assistant for pharmaceutical contract packager Reed-Lane. “While it does provide some breathing room, based on discussions we’ve had with our customers, they want to get their products serialized sooner rather than later.”
Reed-Lane’s Director of Package Development Richard D. Wrocklage adds, “Going live in 2017 will allow our customers to serialize all of their products in a controlled process before the extended enforcement deadline. The availability of serialized capabilities at Reed-Lane will also provide an alternate means for additional customers to become compliant as we move forward in 2018.”
Last year, The LinkLab, a life sciences supply chain consulting group, began a track-and-trace pilot testing program for serialized drug products using an existing Blockchain system for recordkeeping that includes manufacturers, wholesalers, and dispensers. Plans call for program results to be reported later this year to the pharmaceutical industry and to the FDA.
Blockchain technology is perhaps best known as a component of digital currency Bitcoin. Blockchain uses cryptography to allow participants on the network to add secure transactions to the network without requiring a central authority. The goal is to prevent any drugs into the system that do not come from the originating manufacturer.
Another initiative is the Open-SCS Working Group, which partners with the OPC Foundation to help the healthcare industry support product serialization in an effort aimed at patient safety, drug quality, and healthcare affordability. The group's OPEN-SCS standard aims to provide healthcare manufacturers and suppliers with a low-cost, scalable, secure and flexible integration platform for accelerating the deployment of packaging serialization solutions to meet regulatory compliance.
The Healthcare Distribution Alliance, says Rodgers, has been working on the design of their future Verification Router Service, which he says is “aimed at the wholesale distributor’s DSCSA 2019 salable returns problem, but which could end up morphing over time into a viable solution for the industry in 2023.”
HDA, in collaboration with ValueCentric, LLC, recently launched “Origin,” a Product Data Source, a central data repository that hosts verified Global Trade Item Number (GTIN) information. The service enables the secure, accurate and efficient exchange of pharmaceutical product master data between manufacturers and their supply chain partners to help comply with DSCSA regulations.
GS1’s Healthcare US Initiative integrates GS1 standards into supply chain processes, with its mission to “increase patient safety, supply chain security and efficiency, traceability and accurate data synchronization in healthcare.”
Work to be done
“The involvement of the FDA in evaluating the 2023 requirements and potential solutions is vital because only they will be able to sanction whatever the industry might propose,” says Rodgers. “In my view, their kickoffs of piloting and public meetings represent a late start, so things will need to accelerate quickly or we risk the need for more delays in 2023. We need to have agreement between the FDA and the industry about how the 2023 challenges will be met by the end of 2020 because systems will have to be developed, tested, and deployed. That’s a lot of work to be done between now and then.”
Looking ahead, Rodgers says, “After the flurry of the serialization deadline is behind us, manufacturers are going to turn their sights toward what they can do with all those serial numbers—beyond just complying with the law.”
Respondents to the 2016 PMMI “Pharmaceutical and Medical Devices—Trends & Opportunities in Packaging Operations,” report identified regulations as the single most pressing concern among industry professionals. The report says, “For the pharmaceutical industry, the track-and-trace requirements involved with serialization (and eventual aggregation in 2023) require new sensors, software, and automated machines, as well as new integrated systems to track, monitor, and verify products throughout the supply chain.”
So, as difficult as reaching compliance deadlines may be for the pharmaceutical industry, PMMI’s study shows opportunities abound for the packaging community. For suppliers, for example, there’s product to be sold and partnering relationships to be established and nurtured. For manufacturers concerned about the financial investment necessary to meet serialization deadlines, justification could come from insights gleaned from better understanding of their internal processes, and from working more closely with their vendors and reassuring patients that their products are safe and efficacious.
DSCSA and product identifiers
The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) was signed into law Nov. 27, 2013. Section 202 of the DSCSA added section 582 to the FD&C Act. This section established product tracing, product identifier, and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of a product through the pharmaceutical distribution supply chain.
The agency’s June 2017 draft guidance points out, “An important requirement of the product tracing scheme outlined in the DSCSA is the product identifier. … Section 582 requires that each package and homogenous case of product in the pharmaceutical distribution supply chain bear a product identifier in both a human-readable form and on a machine-readable data carrier. The product identifier includes the product’s standardized numerical identifier, lot number, and expiration date.”