Recap of the HDA Traceability Seminar- DSCSA 2024

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This years conference did not disappoint and lots of useful insights. We enjoyed a productive conference and it was great hearing from experts and catching up with peers!

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Here is a list of some key topics from HDA Traceability and some thoughts for each concern.

1) Stay in regular communication with trading partners, contractors, regulators, and others.

- Continue efforts to share how things are going. We heard several participants and speakers say they would appreciate more feedback on their performance. If you are receiving data from a supplier, keep them informed about any issues you are encountering. Can you successfully load and utilize the data? Are there any "errors" that you are noticing?

-If you are not yet prepared to receive data, communicate the expected readiness timeline to your suppliers. If you are not ready to share data, inform your downstream partners about your latest plans. A brief virtual meeting, phone call, or email can greatly contribute to moving forward. Some leading figures in the industry are organizing regular meetings for suppliers or customers to keep them updated and address any inquiries.

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2) No slowing down, move to exception handling prep and mock audits if you feel solid on core requirements.

- Exception handling will be a part of everyday work. Take time now to prepare for dealing with various exceptions. HDA and PDG have great resource documents that can help you understand the potential issues you may have to deal with. We can assist you in developing a plan to keep the product moving and address any concerns.

- Are you prepared for Nov. 27th? We suggest conducting an independent audit of your processes to avoid internal or service provider bias. We have developed a comprehensive assessment process to evaluate your readiness for ALL aspects of DSCSA. We will assess the role or roles you fulfill according to the DSCSA and scrutinize your policies and procedures to ensure they meet DSCSA requirements. Our team has conducted over 40 assessments of trading partners who serve the industry as manufacturers, distributors, repackagers, 3PLs, and dispensers. We offer an external perspective on your compliance to identify even the smallest gaps in meeting the requirements.

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3) All trading partners need to take a serious but quick look at their readiness for November.

- Will you be ready in time? Will your suppliers and customers be ready and are you aligned and supporting their schedules? Should you submit a WEER?

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4) Data exceptions at the point of dispense could lead to serious problems for pharmacies. Work to avoid now.

- It is essential for your organization to provide stabilized product data to pharmacies before November 27th, 2024. Delays or lack of data can lead to serious situations for pharmacists. Pharmacists have a professional responsibility to ensure the safe dispensing of medicine which will soon not be possible without serialization data for most pharmacies.

- In cases where the product is known to be safe but data is pending, pharmacists face the difficult decision of potentially harming a patient by withholding the medication or violating DSCSA law or guidance.

- To avoid these situations, it is crucial to take action now. When a product is potentially life-saving, the pharmacist's decision becomes extremely critical.

- Members of the State Board of Pharmacy have emphasized the expectation for pharmacists to prioritize the patient's well-being and then address any issues related to accurate data at a later stage. The FDA guidance regarding the ability to dispense without complete data has been somewhat unclear.

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5) Submitting a WEE Request may raise the risk of “becoming a target”. However, not submitting a WEE Request for your product may be even worse, especially if your partners need to include you on a WEE Request to mitigate risks or if it could affect product movement later on.

- The FDA shared they have received several hundred WEERs before August 26 related to the latest request. There are estimated to be tens of thousands of trading partners under the DSCSA, and we have heard the majority of distributors, dispensers, and some manufacturers express doubt that they will be fully ready by November 27th, 2024.

- The concern is that the lack of WEER filing could give the FDA and the industry a false sense of readiness, leading to panic as the date approaches. Act now! Do not delay further to determine if you need a WEER and get it submitted soon. November 27th is less than 60 business days away!

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6) Make sure you have clear ownership for all aspects of DSCSA as you move away from project teams to operations.

- The team responsible for implementing and rolling out DSCSA at your company may have done a great job getting everything ready. However, does everyone in the organization know their role? Have all aspects of DSCSA been assigned to a person for responsibility? DSCSA is not just a program to operationalize; there are many requirements that need to be integrated into everyday operations. It's crucial that everyone works together to ensure that their responsibilities are being carried out.

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7) Get any GTINs you package in the VRS lookup directory and monitor downstream experience.

- If you are a manufacturer, the VRS lookup directory is a tool that allows others in the supply chain to electronically verify your product. DSCSA requires all trading partners to verify products for various reasons. If a downstream trading partner needs to verify that the product data matches the original packaging data, they can use the lookup directory and VRS to contact the manufacturer.

- The majority of manufacturers support VRS and the lookup directory, which enables quick responses to product verification requests. This automated process eliminates the need for using emails or other methods for verification. Most trading partners expect manufacturers to support this system to help them comply with DSCSA regulations.

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8) Make sure anyone in your organization who can get any type of inquiry has procedures and knows what to do.

- All trading partners need to ensure they have systems and processes to demonstrate full compliance with DSCSA (including documented and training-supported SOPs).  You should have a clear understanding of how all communications and activities related to DSCSA will be handled within your organization.

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9) NDC 10 to 12 digit conversion is going to be the rising next big challenge by next year. Look for FDA finalization end of 2024 or 2025.

- The next thing to think about… the FDA will soon finalize the conversion plan to grow the NDC from the current 10 digits length with variable dashes to 12 digits with common dash locations. How does this apply to our NDCs? How does this effect our systems, ERP, WMS, DSCSA, and more?

- Adding a couple of digits sounds easy until you understand the impacts this will likely have to your broader organization and industry. Packaging changes. System changes. System rules changes. Inventory. Financial reimbursement. The list goes on. We recommend you start having these conversations with your team and map out the touch points of this change. We can help you begin planning including impacts and budgets needed.

10) Reach out if you want to know more or how we can help you make it down the home stretch for DSCSA and any contact us if you have any questions at info@tencountconsulting.com

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