Spotlight on FDA Draft Guidance During June 2022 Customer Advisory Board Meeting

June 30, 2022

Pharmaceutical professionals across the industry should be aware of the FDA’s recent draft guidance on verification systems under the DSCSA, published in March 2022. This was covered as the spotlight topic in LSPediA’s June 2022 Customer Advisory Board Meeting held June 28.  

Recently hired Sr. Director of Quality Assurance Jami Vincent gave a brief presentation covering lot tracing and serial tracing verification as well as processing of saleable returns. In summary, manufacturers must have a VRS, ASN, and EPCIS file. Wholesalers must utilize VRS for suspect product investigation and saleable returns. Vincent noted that LSPediA will additionally host an informational webinar on July 14, 2022 to go deeper into the guidance. Register here

“We encourage you, whether you’re a manufacturer or wholesale distributor to come to the webinar with any questions or concerns and participate in this discussion on what this guidance means for you as trading partners,” Vincent said. “We’d be happy to speak with you on it.

CEO Riya Cao gave an overview on the upcoming release of OneScan 6.0 which is set to roll out on July 2, 2022 as an included upgrade for all OneScan customers. The new features include:

  • API call to support serialized order detail for shipment
  • Master Data Audit Trail
  • Virtual manufacturer EPCIS Transformation
  • EPICS Investigator rule updates and new Improvements
  • Edge and EPCIS new Improvements
  • Serial Request UI/API enhancements

LSPediA plans to release some minor release updates for OneScan 6.0 as well. Currently version 6.1 is scheduled for release in October. Training on OneScan 6.0 will be available as an on-demand webinar beginning on July 15, 2022.  

The guest speaker for this CAB meeting was Mark Karhoff, founder of Ten Count Consulting, a firm that specializes in DSCSA and Pharmaceutical Supply Chain Management. Karhoff recently worked with the National Association of Boards of Pharmacy (NABP) on a pilot to gain clarity and understanding with state regulators. They came up with 18 functional gaps for state regulator interoperability and further expanded on five critical gaps.  

The outcome of the pilot is that NABP will lead by authorizing state regulators and dispensers, facilitate communication between regulators and trading partners, and work with standards organizations (such as GS1) and solution providers to build on pilot work. More information on the pilot can be found here.

The next Customer Advisory Board Meeting is scheduled to be held on August 30, 2022.