The Importance of DSCSA Compliance

Many Unprepared for New Guidelines

With the stabilization period deadline approaching quickly, pharmaceutical partners must be ready to adhere to new traceability and interoperability requirements. But a troubling number of partners haven’t made enough progress to reach these new standards, a statistic troubling to partners, the FDA, and one that should trouble consumers as well.

While Phase 2 of the Drug Supply Chain Security Act was supposed to come into effect last November, a stabilization period has granted pharmaceutical partners an extra year to adhere. However, the November 27th deadline is quickly approaching, and FDA officials announced that this deadline is firm. Manufacturers, distributors, and healthcare providers must be prepared to exchange EPCIS interoperable, product-level data across the supply chain… and the truth is, many aren’t ready.

In June, the Partnership for DSCSA Governance (PDG) hosted a joint public meeting discussing DSCSA implementation and stabilization efforts, allowing industry leaders to discuss progress made to adhere to these standards. While progress has certainly been made since June, many pharmaceutical players remain unprepared, including major wholesalers and manufacturers. However, making progress simply by adhering to requirements isn’t the only issue.

Why Updated Regulations Matter… and How to Be Prepared

Counterfeits remain a real threat throughout the United States. Recent reports found Ozempic counterfeits infiltrating the supply chain, with counterfeit boxes containing the same serial number on all packages. A third-party review of the product detected this complication, exhibiting the lack of quality systems and processes within that particular supply chain. Instances like this are far from uncommon, highlighting the importance of DSCSA Compliance and working with a trusted solution provider to help you comply.

As the leading GS1 Conformance Testing Platform, Gateway Checker has a suite of services designed to help you protect the integrity of your supply chain and conform to necessary DSCSA Standards.  

Keep your supply chain safe. Take a look at our traceability platform and conformance testing solutions, to see how we can help you prepare for the upcoming DSCSA regulations. 

Or, feel free to contact us to learn more.

 

HDA Traceability Seminar Insights

The 2024 HDA – Healthcare Distribution Alliance Traceability Seminar was an amazing opportunity for pharmaceutical industry leaders to discuss DSCSA compliance challenges, and present innovative solutions to help partners remediate these challenges. Below, we discuss some important HDA Traceability Seminar Insights. One of the major takeaways from the conference was the role of Waivers, Exceptions, and Exemptions (WEEs) on DSCSA deployments.

DSCSA Compliance Clock is Ticking

With the deadline for compliance less than 3 months away, the compliance clock is ticking, and ticking fast; however, many appear unprepared. Despite reasonable efforts, many pharmaceutical supply chain partners are far from fully compliant, and likely won’t be by the time the stabilization period ends this November 27th.

The FDA has exempted small dispensers (25 or fewer full-time employees for the corporate entity owning the dispenser) from upcoming DSCSA electronic and data-driven requirements; these small dispensers account for about 1/3rd of total dispensers. What remains unclear is whether distributors who ship to these dispensers will also be exempt for those specific transactions.

Furthermore, the FDA cannot guarantee all of those who apply for WEEs will be answered by the end of the stabilization period, and the recommended deadline to submit these requests ended nearly a month ago.

The ambiguity over who is and who isn’t exempt and the indefiniteness of WEE approval could have detrimental implications on pharmaceutical supply chain integrity. Furthermore, handling common exceptions has proven difficult for big wholesalers and other partners, likely to further inhibit pharmaceutical supply chain security.

How Gateway Checker Can Help

The good news? Gateway Checker’s services provide wholesales, distributors, dispensers, and logistics providers the capabilities necessary to handle a variety of common exceptions, including:

  • Resending of a file with corrections (even after acceptance)
  • Reconciliation of partial shipments/short shipments
  • Digital instantiation of products with no corresponding EPCIS data (only to be used in accordance with SOPs)
  • Visibility into EPCIS errors

See for yourself how Gateway Checker simplifies DSCSA Compliance. Explore our features for yourself, or contact us to discuss your specific needs.

Gayr Lerner representing Gateway Checker at the 2024 HDA Traceability Seminar in Washington, DC.