After an insightful PDG-FDA Public meeting on June 17th/18th in Washington DC, it is clearly time for all stakeholders to understand where they are on DSCSA and ensure they are not at risk of non-compliance for the federal law and related guidance. The updates from trading partners across the supply chain including manufacturers, repackagers, distributors, and dispensers along with inputs from the FDA, state boards of pharmacy, as well as service and solution providers painted a challenging picture in the limited months ahead.

What should your company be doing in light of all of this?

We step through what we learned along with some next steps you should be considering:

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What Did We Learn?

Manufacturers- It appears most manufacturers have now established data connections with their direct customers or have started putting data on portals for those not yet receiving EPCIS. The actual data flowing is still growing and appears to have risen to over 50% at many distributors but it was highlighted that challenges still remain. These include manufacturers still not aggregating on 100% of shipments, missing/misaligned setup master data as well as other technical challenges.

Distributors- While many distributors appear to now be receiving data more regularly, most are just beginning to provide similar data outbound for secondary distributors or dispensers. Challenges outlined included the previous mentioned inbound data incompleteness, installation of new equipment/processes and lack of readiness to receive data by downstream trading partners.

Dispensers- It appears only the largest dispensers in the industry are regularly receiving limited data for testing or production usage and often this is where there are direct shipments from manufacturers who are providing. Larger distributors are beginning to provide the data that is available but there remains a significant climb especially from secondary distributors. Dispensers also pointed to the significant factors that are putting pressure on pharmacies today and DSCSA is just one of broad range of topics they are being asked to address including compounding regulations, evolving licensure, vaccine delivery, PBM terms, and other.

State Regulators- Also highlighted the significant challenge in learning, communicating, and eventually ensuring compliance with DSCSA. Many states are still working on ensuring compliance with earlier requirements of DSCSA including ATP checks, suspect product handling, and ensuring only serialized product (with exemptions). It was also highlighted that manufacturers, and distributors need to ensure that their call centers (including quality, product complaints, customer service or others) know how to handle product verification or product tracing requests from regulators and respond within 24 hours.

FDA- outlined the recent published small dispenser exemption and further amplified that there will be no further extensions to the stabilization period ending on November 27th, 2024. It was highlighted that the recent notice included a recommendation for any trading partner who is not exempt and believes they will not be fully ready, to submit a WEER (Wavier, Exception, & Exemption Request) by August 1, 2024.

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What Should My Organization Be Doing?

1. Develop an Assessment of Readiness for November 27th, 2024 requirements. This can be done through a detailed review of the law, guidance, and learning the best practices of the industry based on guidelines, blueprints and other documents. Ten Count offers various assessment or effectiveness check options that can help your organization whether you are a manufacturer, repackager, distributor, dispenser, or 3PL. We have completed over 40 such checks across the industry at a large variety of clients. We also offer a variety of options for more or less DSCSA experienced organizations.
2. Analyzing the Need for a WEE (Wavier, Exception, Exemption) Request. Some have highlighted this should be a last resort but the reality is that based on the above, the FDA should expect a significant volume of WEERs. The data flow in itself is the biggest indicator that it is becoming unlikely that there is sufficient time to setup, test, onboard and stabilize the exponential amount of data involved in DSCA compliance. We recommend working with industry groups and checking with peers as industry alignment remains critical. Ten Count can help you in evaluating this option and provide support options along the way.
3. Plan for Exception Handling. Early adopters in EPCIS who have been exchanging files with partners for several years, are suggesting to not under estimate the effort to send or receive serialization data. Every connection with a trading partner brings a variety of challenges that may require either or both organization to trouble shoot. Since DSCSA requires your organization to ensure you have matching serialized transactional data with all non-exempt product, it is paramount to ensure you are ready to handle exceptions to avoid product becoming quarantined or considered potentially suspect. We can help your organization review the industry developed scenarios and ensure you are connecting with the right peers and partners.
4. Connect and Stay Aligned with the Industry. There are a variety of industry groups that are working in business and technical areas to help ensure alignment on interoperability and other aspects of this important patient safety law. Ten Count offers a DSCSA orientation that includes a basic understanding for leadership or secondary stakeholders as well as detailed training for alignment with industry technical and functional best practices. We also stay connected with leaders in each sector to understand the latest developments in DSCSA.
5. Prepare to Claim Your Pulse Profile. NABP has developed a solution that will allow state regulators and other trading partners to obtain your contact information, learn business identifiers you have chosen like GS1 GLNs for any trading partner, and eventually perform verifications when required for dispensers. While there is no central system related to the storage and movement of transactional data, even the most experienced solution providers will become out of date and inaccurate without a neutral collaboration point that is based on trading partners voluntarily updating. GS1 has created standards as well as businesslocation identifiers (GLN) but these require alignment by the eventual product owning organization with other business identifiers such as license numbers, NCPDP, DEA and others. Trading partners also have the ability to establish hierachy records where they wish to reference a higher corporate GLN for DSCSA ownership as has become a common practice in the supply chain. Ten Count will pass along further updates as NABP shares updates with the industry.

It is hard to predict what things will look like in the next few months but it is clear we still have a long ways to go for DSCSA to be fully operational and organizations across the supply chain demonstrating interoperability and full readiness. We are proud to be a trusted partner to many organizations across the pharmaceutical supply chain and are remain committed to helping the industry ensure it is implemented effectively.

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Ten Count continues to offer a free consultation to help trading partners of any size or sector understand their requirements, comply and have processes independently pressure tested while minimizing wasted spend.

Reach out to us through info@tencountconsulting.com

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