Turning uncertainty about DSCSA drug traceability requirements into a business advantage

By Jared Kimble

The pharmaceutical industry has been anticipating the next stages of the FDA’s Drug Supply Chain Security Act (DSCSA) for some time now. The act, which became law in 2013, requires that trading partners in the supply chain – manufacturers, repackagers, wholesale distributors — and dispensers must meet product identification and traceability requirements.

The act is being phased in over a 10-year period, giving the end-to-end supply chain until 2023 to be fully compliant. Draft guidance has required manufacturers to have product identification since November 2017; however, products currently in the supply chain from that time and until November 2018 will be “grandfathered” and likely obtain different treatment.  That requirement extends to repackagers in November 2018, to wholesalers in 2019, and to distributors in 2020. As a global mandate, the DSCSA requires any company wanting to sell pharmaceutical products in the U.S. to ensure proper traceability by 2023, meaning the impact will be far-reaching.

To comply with these requirements, organizations need to have a system in place as quickly as possible to ensure they are ready to meet these requirements.

The sticking point, however, is timing. The FDA has announced delays to enforcement, leading some companies to voice uncertainty whether it’s ever going to happen. They are unsure what to do and when they should be ready.

This is not a straightforward task. Let’s take the next stage in the act – repackaging – as an example. Pharmaceutical companies typically have several repackagers as the drug makes its way through the supply chain. A manufacturer might do bulk manufacturing, and those products then get repackaged and the process refined as the product makes its way down to the distributors and into hands of healthcare providers and patients. So not only will repackagers be required to imprint the product identifier, they must also verify that the product received has proper identification before accepting ownership and engaging in further transactions with that product.

Future proof

In the future, trading partners will need to consider how a drug can be traced throughout the supply chain to safeguard against counterfeit or falsified products. That means having a readable code that can be applied to product packaging, so it can be scanned and traced at any point.

To be DSCSA ready, companies will need to assess their technology capabilities – both the solutions to enable traceability and the instrumentation to scan and read the code – and implement process change. There is a need to understand the end-to-end process in terms of what has to happen along the supply chain and adapt processes to ensure they are more aligned with serialization.

Repackaging will need careful consideration since the current process of repackaging bulk manufactured products under different names, or different packaging, or even unmarked packaging won’t work under the DSCSA framework. In the future, the repackaging will need to have an identifier on it as it makes its way through the supply chain.

The uncertainty around what will happen next with the act may be hindering progress for some companies. However, there are many compelling reasons to improve the overall supply chain process beyond the FDA act and other global serialization requirements.

By maximizing the supply chain, companies can reduce cost and realize greater efficiencies. Another invaluable benefit is brand protection. Counterfeit or falsified products, or even unbranded products that are sold ostensibly as the legitimate brand can harm a company’s reputation if patient safety is compromised. Moreover, reputation aside, companies do care about the safety of patients, so anything that puts that at risk is a concern for a product manufacturer.

Another important use of traceability is to combine that data with analytics to gain insight into asset management and logistics in real time. In so doing, manufacturers can quickly determine where there might be undersupply or oversupply and use that information to redistribute products according to need.

Ultimately, the FDA will push ahead with DSCSA because securing the supply chain has become a priority worldwide.

However, rather than remain fixated on the FDA’s phased approach to the act, the industry can pre-empt these steps and begin implementing traceability to ensure they are compliant when the time comes and to gain business advantage along the way.

Jared Kimble head shotJared Kimble has over 14 years of experience in the life sciences industry. His expertise ranges from software design and development to solution architecture where he is currently the offering lead for Life Sciences Regulatory Transformation Services. He lead the management and development effort for many key projects and was involved in several on-site engagements. Before joining DXC, Jared worked as a software engineer developing applications dedicated to providing financial exchange services for banks and financial institutions.

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