Navigating WEE in the DSCSA Landscape

The Drug Supply Chain Security Act (DSCSA) has been instrumental in bolstering the integrity and security of the pharmaceutical supply chain in the United States. However, as the landscape evolves, so too does the need for flexibility within the regulatory framework. This is where Waivers, Exceptions, and Exemptions (WEE) come into play, offering stakeholders the opportunity to seek relief from specific DSCSA requirements under certain conditions.

At Antares Vision Group, we are closely engaged with our customers as they navigate the complexities of submitting a WEE to the FDA. While it remains uncertain which companies will successfully obtain WEE’s, we are actively preparing for the ramifications that these exemptions might introduce.

Understanding the Implications of WEE

WEE’s hold significant potential to impact the DSCSA supply chain. Their primary concern is to ensure that exempt products are identified preventing a cascade of additional DSCSA exceptions. The HDA (Healthcare Distribution Alliance) recently published guidance on the use of EDI 832 transactions to communicate product information to support the Drug Supply Chain Security Act (DSCSA).

This covers how a trading partner should communicate WEE products although this guidance still needs to be adopted and implemented by the industry.

Our Commitment to Exception Readiness

In response to this evolving landscape, Antares Vision Group launched a comprehensive Exception Readiness initiative. This initiative was designed to fortify our customers’ preparedness for the potential disruptions that WEE’s might cause. Together with other solution providers, we are ensuring a unified and robust approach to handling WEE’s.

Exception Readiness Pilot

Antares Vision, through its subsidiary rfxcel, is working with a group of solution providers on a groundbreaking Exception Readiness pilot. This accelerates thead option of exception-handling approaches by piloting industry recommendations and guidelines already in place.

Key Focus Areas

1. DETECT: Ensuring systems can correctly detect errors is the first step in exception readiness. Although the industry knows how to test digital exceptions, simulating digital/physical exceptions is challenging. Antares Vision Group has developed the test cases, processes, and tools required to enable this testing and is sharing our knowledge and tools with other industry partners and solution providers to accelerate industry readiness.

2. COLLABORATE: Once the software detects an exception, a human must be notified to take corrective action. The Exception Readiness pilot implements industry recommendations on “How” to communicate with each other to enable a rapid response. The pilot uses email for human-to-human communication andJSON to automate e system-to-system communication. Piloting a standard to verify “How” to communicate is only part of the effort. We are also piloting “Who” receives theses emails to correct exceptions. As part of this pilot, we are testing NABP’s (National Association of Board Pharmacy) contact list as a common email directory for industry participants.

3. CORRECT: The final focus area of the Exception Readiness pilot is verifying the use of industry-recommended EPCIS (Electronic Product Code Information Services) for data corrections between trading partners. EPCIS is well known and understood for shipping information about a pallet bit it can also be used to correct individual items within a pallet. The use of EPCIS for individual items within a pallet is a focus of the Exception Readiness pilot.

Outcome

Through this collaborative effort, Antares Vision and other solution partners want to accelerate industry-wide adoption of exception-handling processes, ultimately enhancing efficiency, transparency, and compliance in the DSCSA supply chain. By anticipating the impacts of WEE’s and preparing accordingly, the group will facilitate a smoother integration for all DSCSA participants.

In conclusion, while the path ahead is filled with uncertainties, Antares Vision Group is committed to exception readiness. Together with our partners and customers, we are navigating this new terrain with confidence and a proactive mindset, ensuring that the integrity of the pharmaceutical supply chain is maintained at all times.