The National Association of Chain Drug Stores (NACDS) today is praising the U.S. Food and Drug Administration (FDA) for a sound public policy decision that will prevent imminent risks to patients’ medication access, while continuing to prioritize the implementation of the Drug Supply Chain Security Act (DSCSA).
NACDS also is praising the leadership of U.S. Reps. Troy Balderson (R-OH) and Lori Trahan (D-MA), and the engagement of 19 additional members of Congress, who on a bipartisan basis urged the FDA for action this week.
The FDA issued a temporary exemption for eligible trading partners from certain requirements of the DSCSA. 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 since July on this issue. Most recently, in September, NACDS urged the FDA and HHS to act swiftly on this issue, noting the rapid approach of a November 27, 2024, 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 regiments, 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 about 25% – 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.”
Following the FDA’s action today, NACDS President and CEO Steven C. Anderson said, “Today the FDA demonstration true leadership in putting Americans first. This is about continuing the implementation of a highly regarded new law, while avoiding the dreaded law of unintended consequences.”
Anderson continued, “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. As always, NACDS members articulated clearly the real-world situations that they encounter while serving as the face of neighborhood healthcare, 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.”
