October 2024 update: on October 9th, the FDA issued an exemption to stagger enforcement of the DSCSA drug requirements to 2025. Read more about the DSCSA compliance and 2024/2025 implementation timeline in this updated article.
The U.S. Food and Drug Administration (FDA) is giving pharmaceutical trading partners an extra year to comply with certain requirements of the Drug Supply Chain Security Act (DSCSA), following widespread concern that industry players weren’t ready for the original November 2023 deadline. While many may be breathing a sigh of relief at this DSCSA stabilization period, I’d like to suggest that the best path forward is to continue with urgency – without rushing.
Here’s a look at what the FDA guidance means, how to best make use of the extra time, and how to not only prepare for drug serialization by November 2024 but also use this opportunity to improve your processes.
What is the DSCSA Stabilization Period?
The FDA has published two compliance policy guidances establishing a 1-year stabilization period for trading partners to adhere to the final phase of the DSCSA. This stabilization period gives trading partners the opportunity to test, troubleshoot, and mature serialization systems ahead of a new November 2024 date.
The two FDA-issued guidances are:
- Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies
- Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product —Compliance Policies
The FDA has recognized that there are technical and operational issues present between trading partners that may not be resolved by November 2023. These issues have been highlighted by the industry over the past several months and could disrupt patient access to prescription drugs, impacting patient safety.
We’ve written more about the state of the industry and readiness ahead of the DSCSA deadline here.
Given these concerns, the new August 2023 guidance calls for a one-year “Stabilization period” for the final phase of DSCSA.
FDA speakers at the Healthcare Distribution Alliance Traceability Seminar in Washington, DC provided insights into how the stabilization period should be used by trading partners to implement, test, and mature serializations systems to meet the DSCSA regulations while supporting availability of products.
The FDA stabilization period should not be viewed as “enforcement discretion” as we have seen in years past. Trading partners are at risk of enforcement actions if they are not in compliance or not making best efforts to comply with the 2023 requirements.
Consistent movement forward in 2023, 2024, and beyond
There is strong messaging from the FDA that this stabilization period is no excuse to slow or delay DSCSA implementation efforts.
The FDA policy guidance actually states that “FDA generally expects trading partners to have the systems and processes in place to meet these requirements as of November 27, 2023,” not November 2024. This is an important clarification as the law has not been delayed and the deadlines are still in place.
Further, the FDA reiterated their position in the guidance with the following:
“This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.”
It is important to acknowledge that previous requirements of DSCSA are still in effect and must be adhered to. While the industry now has a short opportunity to catch a breath, implementation of the final phase of DSCSA must still be a priority in addition to continued compliance with all current DSCSA requirements.
How to best make use of the DSCSA stabilization period
It is best to start sending data as soon as possible, before November 2024. It will take time to test data exchange and refine processes and staffing ahead of the November date.
Those who already have their serialization systems in place now have an opportunity to mature their systems beyond simply meeting compliance and interoperability. We’ve found many pharmaceutical partners have room for improvement when it comes to data visibility and reporting, as well as efficient exception handling.
An API-enabled solution like Axway Track & Trace makes it easy to integrate your supply chain end to end – from warehouse and product line systems to scanning equipment and point of sale – including with verification systems.
The National Association of Boards of Pharmacy® (NABP®) launched its Pulse digital platform in August to help accelerate interoperability in the drug supply chain. To help protect patients from counterfeit or substandard prescription medications, seamless integration will be especially important, which is why Axway is participating in the Pulse Interoperable Partner program.
This reprieve is an excellent opportunity to not just ensure compliance with FDA guidance, but also free your professionals from time-consuming manual tracing tasks, all while maintaining visibility into the status and location of every product and package.
Find a DSCSA readiness checklist for manufacturers, wholesalers, distributors, and dispensers here, or for pharmacies and dispensers here.
Overcome pharma supply chain challenges with Axway
We’ve spent the past decade helping the pharmaceutical supply chain meet regulatory traceability mandates emerging around the world, including the latest wave of updates needed for DSCSA compliance.
We hear about these types of issues from our customers and colleagues across the industry and have worked with them to find solutions. For example, a common concern involves format compatibility issues:
“I have serialization data, but I don’t have the integration software to map to my partner’s format or to manage EPCIS files.”
85% of the top pharmaceutical manufacturers trust Axway because of our strong reputation for solving thorny integration challenges like this one. We provide software that can bridge formats, protocols, and even enrich data to ensure compliance and reduce manual intervention.
Another common issue is when teams are forced to log in separately to their vendor or trading partners. Axway can offer a more seamless interaction: we support multiple authentication capabilities, enabling your internal teams and partners to log in after authentication or multi-factor authentication as required by your security office.
And if you struggle to integrate with internal systems, compliance tools, or verification services, our leading Amplify API Management platform can help bridge these gaps.
Whether you’re scrambling to comply or looking to improve operational efficiency, Axway has the product solution, people, and expertise to help you meet the key business challenges of DSCSA – and beyond. Let’s talk.
Learn more about how Axway Track & Trace helps organizations address challenges like onboarding, integration, and exception handling in addition to serialization compliance.