Dispensers — the business category that includes pharmacies, supermarkets, and hospitals — are under pressure to comply with the Drug Supply Chain Security Act (DSCSA) ahead of its November 27, 2023 enforcement deadline. However, too many still don't have clear information on what this means or how to proceed.
Their responsibilities under DSCSA include being able to receive files in the EPCIS standard. These files are larger and more complex than ASN, as they record a complete event history of a single item; it's not feasible to process them without a dedicated system.
The enforcement deadline adds the requirement for items to be tracked at the level of the individual package, rather than the lot level, a change that greatly increases the sheer number of files exchanged.
Pharmacies will also need to form interoperable connections with their suppliers, allowing them to exchange and access data as needed for complete traceability. These vital connections, which enable companies to understand the full history and location of a given item, can take weeks or months to create, and must exist separately between each pair of trading partners.
DSCSA is designed to bring about greater patient safety in the U.S. by making all products fully traceable, and by requiring data with every product exchange. This allows instantaneous reactions to recalls, immediate recognition of diverted or dangerous products, and confirmation that each transaction is legitimate. However, pharmacies can face difficult challenges in adapting their systems for DSCSA, not least because they need to continue operating fast-paced, high-pressure public environments while onboarding these transformational changes.
Pharmacies need to onboard EPCIS and hold interoperable connections with their trading partners to properly exchange data for each transaction. On top of that, the project involves managing a massive increase in data and training staff on a number of new capabilities.
Pharmacies must only accept serialized products, meaning that incoming drugs carry a unique product identifier, and is traceable at the individual package level; they also need a way to verify serialized products and process saleable returns.
They cannot complete a product exchange without having received data before, or at the time of, the transaction. As well, if the data is incomplete or missing, or doesn't match the products they receive (including situations where a package's label is damaged or unreadable), they cannot accept the product — instead, they'll need to quarantine it while they determine its legitimacy.
Further, the law states that they must have processes in place to investigate suspect or illegitimate products, and report illegitimate products to the FDA and their immediate trading partners. They'll also need to retain transaction data for six years.
It's important to note that even if your supplier has introduced an online portal that helps you receive their data, this does not fulfill your own DSCSA requirements.
The most important recommendation we can make is to start now. LSPedia’s mission is to make DSCSA compliance easy and stress-free for any pharmaceutical trading partner, but the closer November 2023 is, the more pressure you’ll be under (and, in July 2023, we're already pretty close). Waiting until late in the year poses a massive risk to your business, your customers, and even your trading partners.
In addition to rolling out a DSCSA solution, you’ll need your team to have internalized what it means at the level of everyday business. Are you able to explain DSCSA to your workforce, and ensure there’s broad understanding of how your solutions work with your company’s existing processes and business needs?
You may want to consider creating your own in-house DSCSA experts. LSPedia’s DSCSA training sessions provides interactive, hands-on experience under the guidance of experts in FDA compliance, and limited class sizes enable the sessions to be customized to your organization’s needs.
A slowdown in receiving prescription drugs for your patients just isn’t an option, and meeting your DSCSA requirements shouldn’t create extra checks and labor. Rather, it should be part and parcel of your supply chain operations, and work seamlessly with your existing systems. For example, LSPedia’s Investigator for Exceptions Management is built with hundreds of GS1 data rules, serialization algorithms, and integration APIs to automatically detect the errors that can stall deliveries and guide the resolution process.