How big was last week’s news from the FDA announcing a one-year delay in enforcement of the Drug Supply Chain Security Act (DSCSA)’s product identifier requirement? If you’re a manufacturer rushing to meet the November 2017 deadline, the draft guidance is significant (though long expected). But those breathing a sigh of relief shouldn’t ease off on their serialization efforts: There’s no change to the law, only a temporary pardon for those manufacturers behind on complying with the law.
A Deeper Look at the Delay
The draft guidance describes the FDA’s compliance enforcement policy concerning product identifier and verification requirements for manufacturers, which is set to begin on November 27, 2017. The compliance policy also addresses certain requirements for repackagers, wholesale distributors, and dispensers, namely regarding their requirement to only engage in transactions involving products with identifiers and to verify product identifiers when investigating suspect drugs. Lastly, it addresses repackager and wholesale distributor requirements related to saleable returned products.
But what does the guidance and delay really mean for the pharma industry? It means the FDA won’t enforce the product identification requirement until November 2018. The Drug Supply Chain Security Act (DSCSA) still requires—and the law still states—that manufacturers affix or imprint unique product identifiers (serialized barcodes) on saleable units and cases by November 2017. The bottom-line change is that the FDA, the DSCSA enforcing agency, will not penalize manufacturers who fail to meet this requirement until November 2018.
This was highly anticipated. The FDA held two public meeting last year, and one industry meeting this year, to collect public feedback and status updates. This line in the draft guidance tells the story pretty clearly: “FDA has received comments and feedback from manufacturers and other trading partners expressing concern with industry-wide readiness for implementation of the product identifier requirements for manufacturers.” The issue boils down to two big challenges for manufacturers:
- A limited number of vendors that have the expertise to provide solutions related to information technology systems for data management or specific equipment for packaging or manufacturing lines
- Capabilities and readiness of contract facilities that perform manufacturing operations on behalf of the manufacturer.
Hence the delay. But, how should manufacturers respond to and think about the news? Let’s look at five takeaways.
DSCSA Delay: Five Takeaways
- There is no change to DSCSA requirements. Only the enforcement of manufacturers’ product identifier requirement is on hold for 12 months. The law itself has not changed and isn’t likely to change in the future, despite a far-fetched belief by some that the Trump administration might relax or revoke the legislation.
- The distributor return and verification requirement, currently set for 2019, will likely be delayed as well. The delayed enforcement on product identifiers for manufacturers will probably cause a ripple effect with other requirements. Of course, that’s an assumption. We won’t know for sure if the FDA will delay enforcement until we see it in writing. So distributors need to proceed with compliance projects.
- The delay may impact your internal and external deadlines. Companies we spoke with that have started serialization implementation are staying on course. That’s because changing a funded plan, with deliverable dates established and projects set in motion, often only increases costs. We’re already working with many of these businesses to guide them through the process and address any changes in implementation that the delay might cause.
- The electronic product tracing requirement doesn’t change. Partners in the pharmaceutical supply chain are required to provide electronic Transaction Information, Transaction History, and Transaction Statements (TI, TH, TS—or 3Ts) to downstream trading partners. Companies currently using paper invoices and packing slips must stop and switch to the electronic format—EDI ASN or EPCIS 1.2, for example. Distributors should take note: the delayed enforcement on product identifiers now allows FDA to increase their focus on product tracing requirement – advancing the FDA’s success in prosecuting supply chain security violators.
- Invest in your ASN operation to ensure compliance. There is no doubt that we, as an industry, have done an exceptional job moving toward adopting ASN—despite the big challenges it presents. As that work continues, keep in mind that the ASN documents are legal documents—a required materials for safe and secure drug supply chain. Accepting over-shipments and under-shipments is a thing of the past. Under the DSCSA, all the details on the ASN have to be accurate and the shipment received has to match the ASN. If your current ASN operation is error prone, painful, and full of bottlenecks, reach out to us today, and we’ll show you a fully automated receiving solution that will resolve your ASN issues and streamline your operations.
The Bottom Line: Is the Enforcement Delay Good News?
We think the enforcement delay is a great news: Companies still working toward serialization can now deploy solutions without having to rush ahead of the deadline. And organizations that have completed serialization now have time to stabilize the solution and iron out wrinkles. Serialization is a big undertaking, and serialization solutions are evolving as technologies advance.
Don’t Delay—Get Moving on Serialization with LSPediA
Compliant, effective, and innovative, LSPediA’s RxChain is an all-in-one serialization solution with serial data management, serial warehouse management, and mobile deployment. If your company is tired of error-prone pedigree solutions and underperforming vendors, this enforcement delay presents the perfect opportunity to move on to a new and improved software platform that can manage serialization compliance, ensure ASN quality, and improve customer satisfaction.
No matter where you are in the compliance process, we can help. Contact us today to put your business on the right track.
About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of enterprise software and services designed for pharmaceutical manufacturers, wholesale distributors, and dispensers. With LSPediA, customers can better implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates.
For more information about LSPediA, call +1 (248) 973-2008, email [email protected], or visit our website at www.lspedia.com. For more details about the VAWD solution, please go to https://www.lspedia.com/vawd.