By Gina Shaw
The FDA will give trading partners, including pharmacies/dispensers, additional time before it will begin enforcing enhanced distribution security requirements under the Drug Supply Chain Security Act (DSCSA), the agency announced on Oct. 9, 2024.
Under the new policy, manufacturers and repackagers will have until May 27, 2025, to comply with DSCSA’s enhanced distribution security provisions; wholesale distributors and dispensers with 26 or more full-time employees—which would include most hospital and health-system pharmacies—will have until Aug. 27 and Nov. 27, 2025, respectively. (A previous FDA announcement had granted delayed enforcement to dispensers with 25 or fewer employees.) Trading partners are not required to notify the FDA that they will use the exemptions, but they will only apply to those entities that have “successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.”
Elizabeth Gallenagh, the general counsel and senior vice president of supply chain integrity at the Healthcare Distribution Alliance, noted that the FDA is using its authority under the statute “to basically give sector-wide exemptions under what is known as the waiver, exceptions and exemption [WEE] process.” She stressed that “there is a provision in the law for the FDA to step in and issue a broader exemption for the industry as a whole, which the states have to recognize as well.”
Ms. Gallenagh added that the FDA’s move “is a little stronger than the typical enforcement discretion” from the agency, “and creates the phased approach to enforcement that we have all been advocating for.”
The decision, coming six weeks before full DSCSA enforcement for most trading partners was scheduled to go into effect on Nov. 27, is a welcome relief for many hospital and health-system pharmacies, which had been struggling to obtain the complete data they need from upstream trading partners for full compliance.
“We were extremely pleased that FDA was so responsive to our concerns,” said Jillanne Schulte Wall, ASHP’s senior director of health and regulatory policy. “Our members generally felt that they were ready, with vendors in place for a long time, but then when data started to flow through the system, it was a bit of a shock to see how much of it was missing.”
At the dispenser end of the supply chain, “there wasn’t much recourse,” Ms. Schulte Wall added. “The only thing they could do if they didn’t have the data was not accept the product, which is not really a reasonable solution, especially when in some cases more than half of the data was missing on test runs. That’s a lot of product to turn away.”
Concerns From Congress
Nearly two dozen members of Congress had raised similar concerns and noted the potential for disruption to patient care in an Oct. 7 letter to FDA Commissioner Robert Califf, MD. “While tremendous progress has been made during the stabilization period, there are critical gaps particularly regarding data quality and accuracy,” they wrote. “Although incremental progress has been made since June, significant challenges remain that will invariably create supply chain constraints and delays impacting product from continuing to move through the supply chain. Absent government intervention, there will likely be disruptions that could lead to drug shortages and patients being unable to access critical medications.”
The National Association of Boards of Pharmacy (NABP) also praised the new policy. “NABP applauds the FDA for its decisive action in granting this essential exemption for connected trading partners,” Josh Bolin, the associate executive director for government affairs and innovation, said in a statement emailed to Pharmacy Practice News. “This exemption offers crucial relief to those who have shown their dedication to DSCSA compliance by actively working towards establishing interoperable connections.”
Mr. Bolin added that the exemption “enables dispensers to concentrate on the core DSCSA requirements without unnecessary distractions, ensuring their patients do not face access issues.”
He also offered some caveats for supply chain stakeholders. “We urge dispensers to stay alert against vendors pushing nonmandatory technologies, [such as] digital credentials.” He added that “this exemption specifically applies to products exchanged between eligible trading partners who have successfully connected or made documented efforts to connect with their downstream partners.”
As for next steps, “the NABP remains committed to aiding the supply chain in navigating the complexities of DSCSA implementation,” Mr. Bolin said.
A Vendor’s Take
Any trading partners who do not need to rely on the exemptions should plan to be ready to exchange DSCSA transaction information and statements, and meet all of the act’s other requirements, by Nov. 27, said Neal Long, the CEO of DSCSA compliance solution vendor ConsortiEX. “Despite the deferment, ConsortiEX will continue working with our customer’s supply chain partners to satisfy all DSCSA requirements, as soon as made possible by industry trading partners,” he said. “In preparation for the new 2025 deadline, we encourage dispensers to pay special attention to DSCSA’s verification requirements, which are the cornerstone to preventing adulterated or counterfeit drugs from entering their supply chain.”
Pharmacies and others in the supply chain should not view the new phased-in enforcement as any sort of “get out of jail free” card, Ms. Gallenagh said. “While you don’t have to apply to FDA for a WEE under the new policy, you should be able to demonstrate that you have, in good faith, put systems and processes in place for [DSCSA] compliance. The agency was pretty strong in their language, essentially saying, ‘If you can exchange data, then do so.’”
This policy “is really to give relief to those who have had delays in getting complete or accurate data, to allow them to work out those problems,” she added. “I doubt that anyone is going to have the appetite to move those dates back any further.”
The new phased-in enforcement deadlines should give hospital and health-system pharmacies a chance to test their systems more stringently, Ms. Schulte Wall noted. “They can still work with their supply chain partners to figure out what’s working and what’s not. It’s essentially a longer window for troubleshooting and patching up gaps in the system in a way that isn’t going to impact patients adversely.”
The sources reported no relevant financial disclosures.