When the U.S. Food and Drug Administration (FDA) delayed the required implementation of the Drug Supply Chain Security Act (DSCSA) in August 2023, those who weren’t quite ready likely breathed a collective sigh of relief. Although preparations have been underway for more than a decade, there are a lot of moving parts to address. Concerned that premature implementation may have a negative impact on consumers’ access to their medications, the FDA offered an additional year as a “stabilization period” to give stakeholders the time needed to get things right.
That period ended in November 2024, triggering required compliance with DSCSA rules for some. However, the FDA also gave certain entities a little wiggle room through exemptions — but the deadlines are fast approaching in the year ahead.
What is the DSCSA?
According to the FDA, the DSCSA outlines “steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain. This helps prevent harmful drugs from entering the U.S. drug supply chain, detect harmful drugs if they do enter the supply chain and enable rapid response to remove harmful drugs from the supply chain to protect patients.”
Signed into law on November 27, 2013, the DSCSA was created in response to several critical incidents in which patients were either harmed or died as a result of counterfeit or contaminated drugs that made their way into the pharmaceutical supply chain, according to the authors of a January 2024 JAMA Health Forum article.
Writing that the DSCSA “expands prior efforts to install pharmaceutical supply chain safeguards,” the authors said the Prescription Drug Marketing Act of 1987 and additional efforts to improve drug safety in the years that followed were still not enough.
“In 2007 and 2008 … a string of deaths following heparin administration arose in the US,” the authors wrote. “A federal investigation found that heparin produced in China and distributed domestically had been adulterated with oversulfated chondroitin sulfate, likely for economic gain. While the FDA had some oversight of foreign drug manufacturers, the Prescription Drug Marketing Act proved insufficient for prompt tracing of medical products in the supply chain.”
Then, in 2012, a “multistate fungal meningitis outbreak caused by contamination of methylprednisolone acetate at a Massachusetts compounding pharmacy further underscored the limitations of existing law,” they explained. “The pharmacy shipped unsterile drugs and used expired ingredients, resulting in 64 deaths. Subsequent Congressional investigations revealed that the FDA’s slow response was partially due to limited tracing capabilities. To remedy this shortcoming, Congress passed the DSCSA the next year.”
Stabilizing for DSCSA
In its announcement about its decision to delay implementation, the FDA provided context for its decision:
- “… The DSCSA requires trading partners to provide, receive and maintain documentation about prescription drugs and their chain of ownership from manufacturer to dispenser as the drugs are distributed in the U.S. supply chain. Currently, these entities can choose to provide such information either electronically or in paper format.”
- “Those DSCSA requirements are scheduled to change on November 27, 2023, and will include requiring trading partners to provide, receive and maintain documentation about products and ownership only electronically. The stabilization period will accommodate an additional year, until November 27, 2024, to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems.”
- “The stabilization period is intended to avoid disruption to the supply chain and ensure continued patient access to drug products as trading partners work to fully implement the enhanced drug security requirements.”
“FDA is committed to successful implementation of interoperable systems required under the DSCSA,” said Leigh Verbois, director of CDER’s Office of Drug Security, Integrity and Response in the announcement. “We have heard concerns about supply chain readiness, and we believe that some flexibility will support successful implementation and lead to a stronger and safer drug supply chain.”
DSCSA exemptions and looming deadlines
Just over a month before the new deadline — on October 9, 2024 — the FDA announced that it was issuing an exemption from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners.
“This exemption applies to any product transacted by eligible trading partners, which are trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data,” the FDA said. “This exemption is part of the agency’s broader efforts to avoid supply chain disruptions and ensure patients will not face delays in receiving the medicines they need.”
The FDA said that while significant progress has been made toward full implementation of DSCSA requirements, more time is required to ensure patient needs are met: “…this exemption is intended to support continued implementation of DSCSA without disrupting patient access to their medications.”
Exemption deadlines vary depending on the eligible trading partners involved:
- Manufacturers and Repackagers: May 27, 2025
- Wholesale Distributors: August 27, 2025
- Dispensers with 26 or more full-time employees: November 27, 2025
Additionally, the FDA said it was issuing exemptions from “certain requirements of section 582 of the FD&C Act to small dispensers (pharmacies), and where applicable their trading partners, until November 27, 2026,” noting that this step provides small dispensers more time to “stabilize their operations to fully implement the enhanced drug distribution security requirements of the Drug Supply Chain Security Act (DSCSA).”
For the purposes of these exemptions, the FDA said a dispenser is considered a “small dispenser,” if, as of November 27, 2024, the company that owns the dispenser has “25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.” The FDA notes that pharmacies must make their own determination regarding whether they meet this criteria.
For additional information about the exemptions and process for requesting a waiver or exemption beyond the stabilization period, please see the FDA announcement and/or this FDA resource: The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions.
To further support DSCSA readiness for those eligible for the exemptions, the FDA recently announced that — along with the Partnership for DSCSA Governance (PDG) — it will be hosting three town halls on DSCSA implementation efforts in 2025.
“Interested parties are invited to attend any or all town halls,” the FDA said.
The town halls will be virtual from 1 to 3 p.m. ET on the following dates:
