The Drug Supply Chain Security Act (DSCSA) is Title II of the Drug Quality and Security Act (DQSA) and is designed to protect consumers from potentially harmful drugs.
New requirements roll out on November 27th of each year. Each new requirement progresses toward building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The next anticipated requirements for dispensers will roll out in 2020 and 2023.
Staying up to date with DSCSA dispenser requirements is complex and often confusing. This article will explore the upcoming requirements for dispensers and how they will impact your organization.
What will be required in 2020?
As of November 27th, 2020, hospitals must not accept any products without a 2d barcode (product identifier) on the packaging.
At this point, it’s not clear how a hospital must meet this requirement. Checking for the 2d barcode may be as simple as a visual check or as sophisticated as utilizing a device to scan the 2d barcode. The benefit of using a scanner over a visual check is that it leaves less room for error. Regardless of the method, by 2020 you need to have processes in place to check for the 2d barcode, for what to do if it doesn’t exist, and more.
As the regulations continue to evolve, it makes sense for hospitals to go the route of a higher level of verification. Utilizing a scanner for the barcodes will enable additional verification that the product is what it claims to be and aligns with the initial product order.
What will be required in 2023?
Since it’s further in the future, exactly how to implement the 2023 DSCSA requirement, which builds on the 2020 requirement, is still an evolving concept.
As mentioned before, starting in 2020, hospitals won’t be able to receive anything without a 2d barcode. As a result of this regulation, for example, boxes of hundreds of vials must have a 2d barcode just on the outer box.
In 2023, this requirement progresses to hospitals not able to receive anything without a serial number at the package level. That means, from our example, identification must be on every saleable unit.
Some manufacturers already provide serial numbers on packages today—in fact, there is a previous requirement in place for manufacturers to ensure these are on all products. The 2023 requirement establishes that the hospital shouldn’t accept anything without a serial number or identification at the package-level.
The DSCSA requirements will continue to roll out and evolve over the next few years. Even as we anticipate upcoming requirements, they may change, like the 2019 requirement delay.
Interested in learning more about the upcoming DSCSA requirements for 2020 and beyond? Download this resource to learn more.
