Drilling Down On Distribution

Officials at FDA were on hand to update attendees on the agency's delayed enforcement of certain Drug Supply Chain Security Act track-and-trace requirements.

From Aug. 29-31 in Washington, DC, the Pharmaceutical Commerce team spent extensive time reporting live from the Healthcare Distribution Alliance (HDA)’s annual Traceability Seminar, which was moved up a few months ahead of its normally scheduled date. This marked the second HDA event Pharm Commerce attended this year, with the first being March’s Distribution Management Conference and Expo in Indianapolis.

The matter at the top of the docket was Drug Supply Chain Security Act (DSCSA) legislation. As previously reported by Pharma Commerce, via Section 582(g)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA “does not intend to take action to enforce” rules on exchanging product transaction data, reporting such data to regulators, or verifying salable returns against transaction data (apart from existing methods of verification) until Nov. 27, 2024.

Rather, a “stabilization period” lasting until that time will be enacted, which is intended to provide the pharma supply chain with more time to implement and troubleshoot their systems and processes.

In terms of this show’s editorial coverage, I, with assistance from Associate Editor Don Tracy back at HQ, covered several sessions, including:

• “Implementing DSCSA and Expectations for 2023 and Beyond”
• “FDA Update: Enforcement Policies and Guidances”
• “Exceptions Handling: Mitigating Data Errors to Keep Products Moving”
• “DSCSA Implementation: A Phased Approach and Other Industry Recommendations”
• “Onboarding the Industry: A Status Update and Call to Keep Moving”
• “GS1 Updates on Implementation Guides”
• Roundtable discussions regarding DSCSA

Being that they were all equally impactful, it’s difficult to pinpoint one specific session that resonated with me the most. But in my opinion, the seminar’s first session, “Implementing DSCSA and Expectations for 2023 and Beyond,” was the perfect way to kick off the event.

The presentation aimed to “review DSCSA implementation and expectations for trading partners to achieve interoperable, electronic tracing of products at the package level,” while also taking a look at recent industry guidances that are pertinent to supply chain security.

FDA was clear in noting that this additional time does not signify that trading partners should delay preparation to comply with 582(g)(1); rather, organizations should continue forward as they were, while now allowing extra time to improve their aforementioned systems.

Next on the “Conference Connect” list of coverage is LogiPharma USA, taking place Oct. 4-6 in Boston. For all our conference coverage, including articles and videos, please visit pharmaceuticalcommerce.com/latest-conference.