Conference Connect: The Twists and Turns in Pharma Traceability

In August, supply chain leaders within the industry gathered at Washington, DC’s Marriott Marquis for the Healthcare Distribution Alliance’s (HDA) 2024 Traceability Seminar, perhaps with a greater sense of urgency than
years past.

The goal of the conference was to “learn more about upcoming Drug Supply Chain Security Act (DSCSA) implementation milestones as well as innovative approaches and lessons learned as distributors, manufacturers, and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain.”

Industry members recalled last year's event, when in what felt like only several minutes before FDA was set to hit the stage to discuss the DSCSA, the agency announced two compliance policy guidelines that established a one-year stabilization period until Nov. 27, 2024—thereby choosing to delay enforcement of Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act.

The decision provided those companies working in the pharma supply chain with more time to implement and troubleshoot their systems and processes.

The FDA had held firm in stating that this extra time does not mean that trading partners should delay preparation to comply with 582(g)(1); instead, they should take advantage of the extension by “building and validating” their systems.

These issues were reiterated at the 2024 event's “State of Implementation: FDA’s Perspective” session, in a presentation led by both Leigh Verbois, director of the office of drug security, integrity, and response within FDA's Center for Drug Evaluation and Research office of compliance, and Abha Kundi, JD, MPH, team lead. Their objective was to “review DSCSA implementation and trading partners’ feedback on progress and to achieve interoperable, electronic tracing of products at the package level,” while also examining FDA activities that are in the works.

The agency has also stated the stabilization period will not be extended any longer. However, per Section 582, FDA can issue exemptions, and has done so with small dispensers (less than 25 employees) until Nov. 27, 2026. Other stakeholders can file for a waiver, exception, or exemption (WEE) request, which will be evaluated by the FDA on a case-by-case basis.

At the same time, the agency did express where its priorities lie, which is in providing patients access to their medications in a secure manner. In that light, it decided to reopen its request for information on “implementing interoperable systems and processes for enhanced drug distribution security requirements under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act.”

Other noteworthy sessions at the HDA event included “Filing WEEs: Lessons Learned and HDA Perspectives on DSCSA Implementation and Readiness,” and “Legal Perspectives for DSCSA Compliance Legal Teams.”

Will industry be ready to comply? We’ll have to wait and see, but in the meantime, to read and view all our coverage from the 2024 Traceability Seminar— along with past shows—including behind-the scenes video interviews, please visit pharmaceuticalcommerce.com/latest-conference.