Reaction to Delayed Enforcement of DSCSA Saleable Returns

Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns

The Healthcare Distribution Alliance (HDA) sponsored a meeting on October 28 with more than 100 pharma industry stakeholders to discuss how the Food and Drug Administration’s (FDA) 3-year delay of enforcing the U.S. Drug Supply Chain Security Act (DSCSA) Saleable Returns Verification Requirement will affect its constituents.

This was the first formal meeting about the FDA announcement and marked the beginning of industry discussion that will no doubt continue well into the future. Below are some of the key points raised at the meeting:

Continue with the VRS. The prevailing sentiment is to continue the Verification Router Service (VRS) effort. The enforcement delay was not intended to stop progress, but to give the industry time to ensure readiness.

The industry needs a plan. As one meeting participant correctly called out, the intent to make progress is not good enough. “We need a plan,” they said. To jumpstart this effort, rfxcel and other VRS providers will draft a 2021 road map to work toward DSCSA readiness. The road map will focus on the VRS, but may also address authorized trading partners (ATPs) and other requirements.

VRS is still a “go.” Will the pharma industry really need the VRS in 2023, the year the DSCSA stipulates full serialization of the pharma supply chain? After a healthy discussion, the consensus was that, yes, the VRS will most likely be necessary. Some in the industry anticipated the “retirement” of VRS in 2023 because wholesale distributors would at that time be performing their own verification of serial numbers. However, not all wholesale distributors agreed with this assessment.

Final thoughts

For details about the FDA’s October 23 announcement, see our blog post. And visit our website regularly for more updates about the Saleable Returns Verification Requirement and the VRS.

rfxcel is the industry leader in DSCSA compliance and the VRS. If you have any questions about the delay and what you need to do to be ready for 2023, contact us today.

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