Disclaimer: The information and opinions expressed in this blog are based on the author’s best understanding of the updates from HDA’s 2021 Distribution Management Virtual Conference and Expo and do not necessarily reflect the official policies or opinions of the industry in whole.
Blue Link was excited to attend and be a sponsor for the 2021 HDA Distribution Management Virtual Conference. As we all know, COVID-19 affected business operations and meetings around the world and while we all move safely back to a new normality, the HDA put on an amazing interactive virtual conference. Attendees were able to join live sessions, browse sponsor booths and network from the comfort and safety of their homes.
Blue Link’s booth showcased our Pharmaceutical Distribution Software highlighting the functions which include robust accounting and inventory management features and advanced functionality for traceability, lot tracking, regulatory compliance with the DEA, FDA and DSCSA, EDI integration, barcode scanning and warehouse management. Attendees were able to meet with us directly or simply email our materials to themselves for later consideration.
The conference was attended by key industry players and the HDA held numerous informative sessions and roundtable discussions where attendees from all areas of the supply chain (distributors, software providers, 3PLs, manufacturers and dispensers) could discuss their plans and concerns regarding the 2023 DSCSCA deadline for interoperability amongst other topics. Below we discuss a few key takeaways from this year’s conference.
Use of EPCIS for Interoperability
GS1 standards are the most widely used system of standards in the world and one in particular (EPC Information Services EPCIS Standard Version 1.2) is driving the pharmaceutical industry to help manage interoperability within the supply chain. Interoperability is the ability to securely exchange and make use of information between computer systems. Implementing the use of EPCIS (Electronic Product Code Information Service) files will successfully allow for interoperable data tracing of products at the package level which is outlined in the 2023 DSCSA requirements. These files will include Transaction Information (TI) and allow for easy traceability in electronic format. All companies in the supply chain should be aware of this requirement and be ready with software that can manage and understand EPCIS files.
Good to know: Key players in the industry are indicating that connectivity between systems for interoperability using EPCIS files can take anywhere from 4 weeks to a couple months.
Authorized Trading Partner (ATP) Pilot
When moving products from manufacturers to distributors to pharmacies, it’s important to know exactly where the product has come from and if they are coming from legitimate companies. Authorized Trading Partners (ATP) are those players in the industry who are legitimate and are who they say they are. With that being said, the due diligence that goes into establishing whether a partner is legit or not could take days or weeks and the DSCSA wanted to find a way to minimize this latency and establish ATP identification immediately. In 2020 a few members of the industry participated in The DSCSA ATP Pilot Project to discover the best way to go about ATP credentialing. The pilot provided encouraging insight and leaves leaders of the pilot hopeful that the industry will be able to determine legitimacy of ATP partners immediately.
Overview of Guidance’s Released
Over the past few months, a number of FDA Guidance’s have been released that were discussed. We recommend that you and your team review these as there have been some changes.
- Revised Draft Guidance - Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the DSCSA
- Final Draft - Product Identifiers under the DSCSA - Questions and Answers
- Draft Guidance - Enhanced Drug Distribution Security at the Package Level Under the DSCSA
- Final Draft - DSCSA Identification of Suspect Product and Notification
Looking ahead, Blue Link plans on attending the 2022 Distribution Management Conference and Expo, March 6-9 in Austin, Texas. Be sure to stop by and say hello as we look forward to safely meeting in person!