FDA recommends to submit a WEE Request where needed by August 1, 2024:

For potential to receive notification prior to the approaching end of the FDA Stabilization Period.

We are seeing a growing number of clients in a bit of panic this week trying to determine if they should be submitting a WEE Request for extension of readiness time for DSCSA requirements beyond the approaching November 27th, 2024 end of FDA stabilization period.

The short answer is "It Depends" and here are some questions to be asking to determine if you should be filing a WEER as soon as possible.

If you are a dispensers, Do you qualify under the small distributor exemption which requires less than 25 FTE pharmacist or pharmacy technicians in your corporate structure? If the answer is yes, you should still be working on compliance but have some limited releif for portions of DSCSA for up to 2 years. See this article from NABP for further insights.  https://nabp.pharmacy/news/blog/fdas-small-dispenser-dscsa-exemption/

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If the Small Dispenser Exemption does not apply, you should feel confident answering "Yes" to all of these regardless of which DSCSA roles you perform:

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1. Are you already complying with the existing requirements of DSCSA (prior to November 2023) including authorized trading partner, ensuring product identifiers, and processes to handle suspect/illegitimate product? If the answer is no, you should get to work, as you are already in jeopardy of enforcement actions by state or federal agents and will likely find explaining justification for a WEE difficult.
2. Are you currently receiving full DSCSA data from all your suppliers with each shipment, except where there are DSCSA waivers, exceptions, or exemptions? While there is still just over 3 months before the end of the FDA stabilization, you need to factor in the time you will need to be able to answer yes to question 3 and 4.
3. Do you expect to have exhausted all serialized product inventory without transaction data by November 27th, 2024? In order to be sending outbound serialization data for all products, you will need to ensure any serialized product that was received prior to serialization data is exhausted.
4. Do you expect to be fully connected and sending all serialization data without exception to any non-exempt trading partners receiving title of product from your organization by November 27th, 2024? You may have instances where a trading partner is not ready to receive the data, so expect to have alternatives in place to capturer and provide when needed through such tools as EPCIS or compliant electronic files through secure customer web-portals.
5. Do you exepct to be able to handle all other aspects of the interoperable requirements of DSCSA such as product verification and product tracing by November 27th, 2024? In the event of suspect/illegitimate, processing saleable returns or in cases where trading partners or state/federal agents request, you should have processes and systems in place to handle required verification or product trace request and/or responses. If you have not already, you should review the FDA DSCSA guidance including the EDDS (Enhanced Drug Distribution Security) guidance for further details on what requirements may apply.

If you answered "No" on any of these questions, you should be considering submitting a WEE request or understand the risk that your organization might be facing with non-compliance when the FDA Stabilization Period Ends this November.

We have partnered with RxSCA to develop a 2-hour workshop and workbook to help guide you through the drafting process and prepare for submitting the request.

Please reach out to us through the contact page or our email below for more information.

Need Help Getting Unstuck?

Take a look at our recent post Is My Organization Ready to understand some key trends and steps you should be taking now.

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.

Reach out to us through info@tencountconsulting.com

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