Table of Contents
ARLINGTON, Va. — The National Association of Chain Drug Stores praised the Food and Drug Administration for issuing a temporary exemption for eligible trading partners from certain requirements of the Drug Supply Chain Security Act (DSCSA).
NACDS called the move a sound public policy decision that will prevent imminent risks to patients’ medication access, while continuing to prioritize the implementation of the law.
The association also commended U.S. Reps. Troy Balderson (R., Ohio) and Lori Trahan (D., Mass.) and 19 additional members of Congress who urged the FDA to grant the exemption.
The exemption applies until November 27, 2025, for dispensers with 26 or more full-time employees. A prior exemption applies until November 27, 2026, for dispensers with 25 or fewer full-time employees. This exemption applies to trading partners that have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.
NACDS and allied organizations have engaged with the FDA on the issue since July. The agency’s phased 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,” said Healthcare Distribution Alliance president and chief executive officer Chip Davis.
“While many in the supply chain have made significant progress throughout the stabilization period, some are still struggling to establish data connections,” said Davis. “Ultimately, the FDA made a sound decision based on stakeholder input; we thank the agency for acting with the best interests of patients in mind.
“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.”
Last month, NACDS urged the FDA and Department of Health and Human Services to act swiftly, noting the rapid approach of a November 27 deadline that threatened to lead to “risks to patients’ access to essential medications, worsening of drug shortages, health risks due to disruption of patients’ medication regimens, inflated drug prices due to supply and demand factors, and long lines and bottlenecks at pharmacies.”
NACDS had emphasized that member pharmacies were reporting anecdotally that “their trading partners are providing accurate, consistent and complete [electronic product code information services] data for only 25% to 50% of prescription drug products that dispensers receive,” and that “without compliant data and transactions, dispensers cannot accept ownership of the product and the product either must be quarantined or rejected and sent back to the trading partner.”
With the creation of the exemption, the FDA demonstrated “true leadership in putting Americans first,” said NACDS president and CEO Steve Anderson “This is about continuing the implementation of a highly regarded new law, while avoiding the dreaded law of unintended consequences.”
“NACDS expresses appreciation to the FDA for making a sound decision and expresses appreciation to bipartisan members of Congress who also made their voices heard on a crucial and imminent issue,” said Anderson. As always, NACDS members articulated clearly the real world situations that they encounter while serving as the face of neighborhood health care, and ultimately the FDA delivered a strong public policy outcome that is directly related to the health outcomes of all Americans. As NACDS has stated, the request for a dispenser exemption is not meant to postpone implementation efforts, and dispensers will continue to work with upstream trading partners on DSCSA requirements.”
