Pharmaceutical groups are breathing a sigh of relief today after federal regulators granted many of them more time to come into compliance with strict track and trace rules required by the Drug Supply Chain Security Act (DSCSA).
The initiative is intended to create an electronic track and trace network that allows the U.S. Food and Drug Administration (FDA) to pinpoint the location of any drug throughout the supply chain and drill down to the individual package level, thus improving safety compliance and reducing counterfeiting. To enable that practice, third-party companies like TraceLink have built networks to manage the massive amounts of data required.
The regulation was initially scheduled to be required by 2023, but that has been delayed due to the steep logistics and IT challenges of managing the reams of data that must be generated, stored, and retrieved. The most recent target update was November 27, but industry experts say many businesses would probably have missed that date, too.
Facing that reality, the FDA yesterday again delayed that deadline until next year, setting new deadlines for various trading partners: Manufacturers and Repackagers have until May 27, 2025; Wholesale Distributors have until August 27, 2025; and Dispensers with 26 or more full-time employees have until November 27, 2025.
Pharmaceutical businesses quickly cheered the move. “HDA and our pharmaceutical distributor members applaud the FDA’s decision to grant an exemption for the DSCSA’s enhanced drug distribution security (EDDS) requirements for eligible trading partners,” said Chester “Chip” Davis, Jr., president and CEO of the Healthcare Distribution Alliance (HDA), which is an industry group representing primary pharmaceutical distributors, who connect the nation’s pharmaceutical manufacturers with pharmacies, hospitals, long-term care facilities, and clinics.
“While many in the supply chain have made significant progress throughout the stabilization period, some are still struggling to establish data connections. Given the interdependency of the pharmaceutical supply chain, FDA’s phased-in approach will allow supply chain partners to better align their data exchange processes to ultimately achieve full implementation and also acknowledges the progress made thus far,” Davis said.
“As we continue to make progress toward full DSCSA implementation, HDA and our distributor members will remain engaged with our public- and private-sector partners to share information and education, as we move toward our shared goal: helping patients and providers safely access the medicines they need.”
