FAQ about the Upcoming Changes in the DSCSA
One of the main roles of the U.S. Food and Drug Administration is to ensure that all products, including drugs, are of high quality and safe – and it all starts with enforcing greater accountability in the supply chain of the nation.
Therefore, the FDA is taking steps to adopt more advanced technologies and improve the security of the drug supply chain, mainly through innovations designed to advance the tracing and tracking of pharmaceuticals. This pilot project involves participants being able to use emerging methods for enhanced tracking and verification of prescription drugs in the United States. These participants include repackagers, manufacturers, and additional stakeholders.
You might wonder what the ultimate goal of the new FDA blockchain is.
The pilot program will be considered a success if illegitimate and suspect products are kept from entering the supply chain and reaching patients. Assuming the program does meet that goal, it will inform the development of a new track-and-trace system set to launch in 2023 as part of the
Drug Supply Chain Security Act (DSCSA).
The DSCSA was enacted in November of 2013 by Congress, and it outlines the steps that will be taken to build an interoperable electronic system to trace prescription drugs as they are distributed throughout the United States.
FDA Commissioner Scott Gottlieb, M.D. explains, “We recognize that tracking and tracing products is critical to industry’s ability to detect and remove potentially dangerous drugs from the drug supply chain. This pilot is one of many steps we’re taking to foster innovative ways to improve the security of the drug supply. We’re also focused on making improvements across the other products we regulate, especially related to food and our ability to address foodborne outbreaks. We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain.”
He continues, “To advance these efforts, the FDA recently recruited Frank Yiannas, an expert on the use of traceability technologies in global food supply chains. He’ll be working closely with me on ways for the FDA to facilitate the expansion of such methods, such as blockchain technology, to further strengthen the U.S. food supply. Under his leadership, we’ll continue to leverage all tools available to ensure greater accountability. For the drug track-and-trace system, our goals are to fully secure electronic product tracing, which provides a step-by-step account of where a drug product has been located and who has handled it; establish a more robust product verification to ensure that a drug product is legitimate and unaltered; and to make sure that any party involved in handling drugs in the supply chain must have the ability to spot and quarantine and investigate any suspect drug. We’re committed to staying at the forefront of new and emerging technologies and how they might be used to create safer, smarter and more trusted supply chains to better protect consumer safety and ensure the integrity of the high quality of products they deserve.”
Why Launch a Pilot Ahead of the DSCSA System?
This pilot program is meant to help find the best processes to apply drug supply chain security requirements and will identify characteristics the system will need for enhanced tracking – it will also evaluate the electronic means needed to share this information.
Hasn’t the FDA Done Something Like This Before?
Previously, the FDA had developed and adapted technologies to properly trace and identify pharmaceuticals as they move through all points in the supply chain, including issuing draft guidance on the use of product identifiers with unique serial numbers in order to be able to verify down to the package level.
Furthermore, the FDA has also issued draft guidance for systems that quarantine and investigate suspicious and illegitimate drugs. All of these introductions will work together to translate to a more accurate, rapid response when subpar and illegal products are discovered.
You might ask where the “improved accountability comes into play.
Gottlieb sums it up perfectly as he stated, “As part of our ongoing efforts to protect our nation’s drug supply, today, we’re giving industry an opportunity to test new technologies that can help spur greater accountability for participants in the supply chain and improve our ability to trace prescription drugs at every point in the distribution chain. Using new innovations, we believe we can improve the overall security of our closed system and improve our ability to prevent the introduction of illegitimate products, better detect the introduction of illegitimate products, and enable stakeholders and the FDA to respond more rapidly when such products are found.”
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