HDA 2023 Traceability Seminar: DSCSA Roundtable Discussions


Attendees meet to discuss operational issues related to traceability implementation.

Image Credit: Adobe Stock Images/MonkeyBusiness

Image Credit: Adobe Stock Images/MonkeyBusiness

The recent Healthcare Distribution Alliance (HDA) Seminar held a session that has been popular at previous events—a roundtable—hosted by industry experts in the space. More specifically, it revolved heavily around six aspects that tie directly back to the Drug Supply Chain Security Act (DSCSA), including:

  1. Barcoding, scanning issues, and radio-frequency identification (RFID): Led by Gregg Gorniak, VP of manufacturing operations and data services, secure supply chain lead, Cencora
  2. GLNs and exceptions: Two tables were led by Tracy Nasarenko, GS1’s senior director of community engagement, and Tim Stearns, senior director, industry relations, HDA, respectively
  3. VRS: Led by Herb Wong, SVP of product and strategy Antares Vision Group
  4. Credentialing: Led by Bob Celeste, founder of the Center for Supply Chain Studies
  5. Phased approach, FDA update, and enforcement discretion policy: Three tables led by Tish E. Pahl, principal, Olsson Frank Weeda Terman, Brian Waldman, partner, ArentFox Schiff LLP, and general counsel and SVP, supply chain integrity for HDA respectively
  6. Tracing: Two tables led by Maryann Nelson, regulatory, Cardinal Health and Michael Rowe, director of serialization services at Two Labs respectively

I sat in on topics number one, five, and six. All of the above topics intersect with sessions that Pharma Commerce attended, but if I had to narrow details down to one topic/table, it would be the barcoding, scanning issues, and RFID.

Gorniak’s discussion revolved around pharma RFID testing that has been underway at the Axia Institute/Michigan State University, featuring participating from Cencora, Zebra Technologies, and Fresenius Kabi. Results of the whitepaper are expected to be released soon, but it essentially tested RFID as an alternative to 2D scanning. According to Gorniak, RFID has the potential to read through liquid and blister packs, jumping “leaps and bounds” since 2013.

Sean Murphy, Cencora’s manager of manufacturer operations, stepped in to discuss barcodes—attendees alluded to the code quality of 2Ds, while expressing frustration over different colored barcodes; as an alternative, barcodes, Murphy said, should only be black and white as to not compromise quality.

Be sure to catch the rest of the Traceability Seminar coverage—including sessions related to the above topics—here.

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