A DSCSA-newbies guide to the recent FDA DSCSA announcement
On October 9th, the FDA announced that members of the drug supply chain that have made progress in transmitting electronic data that’s supposed to identify and follow medicines made for the U.S. drug supply will not be penalized if they are still working out challenges in sending and receiving data. This was important because of a November 2024 deadline after which supply chain members could not buy or sell prescription medicine without sending or receiving this information.
The FDA referred to entities who have made major progress as “connected trading partners.”
Follow our Executive Director Shabbir Safdar on LinkedIn, where this content first appeared.
What’s all this electronic data you’re talking about?
The Drug Supply Chain Security Act (DSCSA), passed way back in 2013, envisioned a world in which all medicine was packaged with a unique serial number and electronic data that identified where it came from. When the DSCSA is fully implemented, manufacturers, distributors, and pharmacies can only buy or sell medicine with the electronic data attached and they cannot use medicine without it.
So what’s the deadline?
For the DSCSA to have teeth, there had to be a date by which everyone in the supply chain was ready to send and receive the electronic ownership data and unique product identifier along with the medicine. After that deadline, if you got medicine without the electronic data, it was not usable, not sellable, etc.
This is an enormous information technology project and not surprisingly, a lot of the supply chain wasn’t ready when the first deadline of November 2023 arrived. There were problems with data format interoperability, serialization, and IT integration. Some members of the supply chain underestimated the complexity of the project and hadn’t started work in time to meet the deadline.
In 2023, the FDA gave everyone a year to make progress and called this a stabilization period. Now, as the end of that year approaches, the FDA has said that connected trading partners that have made documented and significant progress will be exempt from enforcement until 2025.
What does this have to do with drug shortages?
After the enforcement deadline, medicine will not be sold without accompanying electronic data. Implementation delays could lead to tremendous supply chain disruption. The FDA is walking a fine line, cajoling the entire supply chain to finish their technology integrations without taking enforcement actions that would create access problems for patients.
The American drug supply chain has become more vulnerable to shortages in recent years for a variety of reasons (honestly that’s an entire dissertation topic in and of itself). While serialization is important, creating a medicine shortage is not an acceptable cost of implementing the DSCSA. I've long admired the FDA for the very difficult job they have in moving us towards compliance without creating impacts on patients.
Does this mean the DSCSA is a failure? Is the DSCSA protecting patients today? Is it “turned on” today?
The DSCSA implements traceability in the supply chain. That means you have the ability to check the ownership history of a medicine to see where it has been. That doesn’t mean it prevents crime. Criminals can still forge this data, but it becomes much harder for them to slip a counterfeit into the supply chain or divert a product from an unsafe source without getting caught.
And, as we showed in a video about an astute pharmacist in Texas who caught unsafe HIV medicine from a supplier who was later indicted, criminals can be thwarted by attentive buyers who can check medicine traceability before dispensing it to patients.
The implementation of electronic records is critical for being able to do traces of medicine at scale, but the DSCSA already protects patients by allowing traces of medicine, though they may be more time consuming to do manually.
Watch to learn how the DSCSA is already protecting patients.
What’s next?
We’re very excited to see manufacturers, distributors, and pharmacies finish implementation of the DSCSA’s electronic systems. We’ll keep you updated on what’s happening in implementation through our YouTube channel and website.