HDA 2023 Traceability Seminar: DSCSA Areas of Improvement

HDA 2023 Traceability Seminar session, “DSCSA Implementation: A Phased Approach and Other Industry Recommendations.” August 30, 2023. HDA 2023 Traceability Seminar, Washington, DC. Image Credit: © Nicholas Saraceno.

As the Traceability Seminar rolls on, the conference dedicated to all aspects of the Drug Supply Chain Security Act (DSCSA) unveiled a session revolving around implementation of the aforementioned legislation, “DSCSA Implementation: A Phased Approach and Other Industry Recommendations,” featuring Liz Gallenagh, general counsel and SVP, supply chain integrity for HDA, Gregg Gorniak, VP of manufacturing operations and data services, secure supply chain lead, Cencora, Tish E. Pahl, principal, Olsson Frank Weeda Terman, and Brian Waldman, partner, ArentFox Schiff LLP.

Although 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, it is not to be misinterpreted in stating that Section 582(g)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act is still going into effect Nov. 27 of this year.

However, by 2024, exchanging EPCIS event files with accurate serialized data falls into compliance with 582(g)(1). Further, says the presentation, trading partners will not be allowed to:

• Sell a covered prescription drug package to another trading partner, unless it contains serialized data for the transacted packages
• Accept prescription drug package ownership if its supplier does not provide serialized ata for the transacted package
• Resell the prescription drug package (unless it provides serialized data for the packages transacted to its trading partner customer

Various challenges come with meeting the Nov. 27, 2024 deadline ,such as the task of having to transition from lot-level (ASN) to package-level (EPCIS) serialized data exchange; wholesaler distributors being unable to operation dual DSCSA compliance systems at receiving (ASNs vs. EPCIS); transitional inventory, which are products bought prior to Nov. 27 without serialized data, but sold after; and data quality consisting of file and data problems.

In an effort to combat these obstacles, HDA has proposed a phased approach consisting over three phases over a two-year period beginning next year. Phase 1 would occur Nov. 27, 2024-Nov. 26, 2025; Phase 2 would span Nov. 27, 2025-May 26, 2026, while Phase 3 would last from May 27, 2006-Nov. 26, 2026.

This has been outlined in the organization’s letter to FDA this past June (beginning on page 7).