In letters to the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA), the National Association of Chain Drug Stores (NACDS) is urging action to prevent “anticipated disruptions in patient access to their medications” after November 27, 2024 – the end date of a “stabilization period” intended to smooth implementation of aspects of the Drug Supply Chain Security Act (DSCSA).
NACDS emphasizes that action is needed soon to prevent 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.
Specifically, NACDS is urging prompt action to “provide an exemption for dispensers until all trading partners can provide the required interoperable, electronic, package level data to downstream dispensers.”
NACDS emphasized in the letters that the DSCSA Stabilization Period has been helpful, and that “dispensers have utilized that time wisely to ensure that we have the necessary systems and processes in place.” However, NACDS stated that member pharmacies are 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.”
NACDS explained in the letters: “DSCSA transaction data travels downstream, typically from manufacturer to wholesaler to dispenser. With less than 60 days before the Stabilization Period ends, it is clear that there is not sufficient time to complete onboarding and testing and ensure that data is flowing accurately, completely, and consistently to dispensers.”
The Association stated clearly that “patient access to their prescription medications is in serious jeopardy unless HHS and FDA take action very soon,” explaining 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.”
“Dispensers’ capacity to procure medications from their suppliers depends entirely on those suppliers’ transactions meeting DSCSA requirements,” NACDS noted. “This situation jeopardizes patients’ access to prescription drugs, through no fault of dispensers.”
NACDS emphasized that the request for dispenser exemption “is not meant to postpone implementation efforts” and that “dispensers will continue to work with their upstream trading partners” on DSCSA requirements.
The letters document concerns raised during recent in-person meetings with the FDA’s Center for Drug Evaluation and Research, and follow additional outreach to the administration.
