Conversations about the Drug Supply Chain Security Act can be difficult. In fast-paced environments where your team juggles competing demands, you might have trouble getting to the heart of the matter with your colleagues — or cutting through the layers of misinformation that surround the new law.
To help you along, we've isolated five important facts about DSCSA enforcement that you can bring to the table.
There's no reason to believe that the FDA will grant enforcement discretion for the November 27, 2023 deadline, not least because the administration signaled multiple times that it will stand. Generally, enforcement discretion would have to recognize that too many obstacles remain for the industry to comply on schedule, which isn't the case: at this point, it’s much easier and safer to comply with DSCSA than to wait.
Not only are the requirements well understood now, but accessible, affordable solutions are readily available. When trading partners across the pharmaceutical industry have the information and resources available to adopt DSCSA, there’s no regulatory rationale to accommodate businesses that don’t take these steps.
Dispensers should be ready to accept and verify EPCIS files, investigate suspect product, resolve exceptions with their trading partners, and otherwise meet all requirements of the law. Businesses that fail to comply will put themselves at risk of enforcement actions, in addition to jeopardizing their trading partner relationships.
As an expert told Regulatory Focus, FDA inspections will likely begin to cover DSCSA compliance, including trading with Authorized Trading Partners, having interoperable data connections, exchanging data ahead of transactions, and using product identifiers.
“It is likely that with the upcoming interoperability requirements taking effect, that FDA will use its inspection force to evaluate DSCSA compliance as a normal part of inspections,” said Howard Sklamberg, a partner at Arnold & Porter. Sklamberg noted that inspectors will want to see that trading partners have the systems DSCSA outlines, including those for tracking Authorized Trading Partners, investigating suspect products, and responding to verification requests.
On a positive note, Sklamberg asserted that systems for meeting DSCSA requirements can overlap with good manufacturing practices. Essentially, DSCSA compliance may work best when it's viewed as part of ongoing SOPs and operations, rather than regarded as fully separate workstream.
The FDA recognized that the GS1 global standard Electronic Product Code Information Services (EPCIS) has emerged as the best tool to carry out its intentions for DSCSA, having gained industry consensus as well as the FDA’s own approval. In its July 2022 guidance, it wrote, “FDA believes that EPCIS is an appropriate globally recognized standard, and FDA understands there is considerable agreement among stakeholders that EPCIS is a suitable standard to adopt for the enhanced drug distribution security requirements.”
The passage emphasizes that pharma businesses ought to “make a collaborative effort” to follow the shared standard. While the FDA says it’d be unreasonable to expect all players to “rely upon a single technological approach,” it does find it appropriate to recommend that they accept the EPCIS standard (and that they use additional systems and practices to ensure confidentiality and security).
EPCIS's strength lies in the fact that each file is entirely composed of events, providing a detailed look at each step in an item's history, including manufacture, aggregation, distribution, and sale. As such, EPCIS exchange between organizations, whose personnel can leverage interoperable connections between systems, provides strong traceability and transparency.
Trading partners who do not onboard the necessary connections to exchange EPCIS files risk damaging themselves and their partners. As LSPedia CEO Riya Cao said during a September 2022 webinar, “There’s no looking back. The FDA has confirmed it, and the industry has conformed.”
EPCIS files are much larger and more detailed than ASNs or previous transactions records. They consist of events, tracking every point in a product's history since its manufacture. Reading for a problem in an EPCIS file manually, whether in a printout or on a screen, is extremely time-consuming. EPCIS files are incredibly precise for tracking where an item's been and how it got there, but the tradeoff is size and complexity.
With the final DSCSA enforcement deadline, every trading partner across the prescription drug supply chain will be tracking each shipment at the item level. This will create a hundredfold increase in the number of EPCIS files exchanged over the course of 2023; even with aggregation to cases and pallets, this jump, in a relatively short span of time, will seem like a tidal wave, particularly for companies who don't have solutions in place for DSCSA data.
This means that the biggest potential danger of information overload is the accompanying leap in exceptions, given the massive boost to both complexity and volume. The combination of more data and more complex data means that trading partners need to be prepared to curate, track, and investigate that data. Without dedicated systems, this will be a major challenge.
Trading partners of all sizes need to take exceptions seriously. Though product levels won't increase, the amount of data created for them will — and the rate of data errors will see a corresponding increase.
It's crucial to understand that under DSCSA, if the data is missing or doesn’t reflect the product as delivered, the trading partners involved must quarantine the product, and report and investigate the issue. At that point, movement stops, and the product can't be received or sold until the data matches.
Generally, the closer a medication is to reaching the patient, the more difficult and time-consuming an exception is to correct. Given the complexity of EPCIS files, the massive increase in their exchange, and the interoperable access and point-to-point collaboration required to trace problems, trading partners are going to want to ensure that any issues can be identified and resolved early and thoroughly.
Moreover, exceptions can be caused by alarmingly ordinary problems: split shipments arriving too far apart; labels being damaged or torn off boxes; simple data errors. By the end of 2023, they'll be a common part of life in the pharma supply chain, despite carrying potentially heavy consequences if they go unresolved.
A strong exceptions management solution can save you plenty of time, money, and stress. LSPedia's Investigator can ensure that most are caught before they can cause a problem, and that you and your trading partners are equipped to deal with them easily via automated alerts and a guided resolution process.