Organizations representing pharmacies and pharmacists are urging that the Food and Drug Administration (FDA) adopt a phased, stepwise approach to the implementation of the enhanced drug distribution security (EDDS) requirements of the Drug Supply Chain Security Act (DSCSA) that are scheduled to take effect on November 27, 2023. The action would go a long way in helping to minimize the potential for supply disruptions and ensure that there are no interruptions to patient care.
On July 14, the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) sent a letter to FDA requesting that the Agency “use its authority under the law for dispensers to comply with the EDDS requirements no earlier than February 27, 2026.”
The groups stated, “Our member organizations support a phased, stepwise approach to ensure that all sectors of the pharmaceutical supply chain have adequate time to stabilize the complex systems and processes necessary for efficient transactions across the supply chain. To be clear, our support for this approach is not to delay all implementation activity. We believe during the phased period it is important for trading partners to continue on the path toward package-level tracing and enhanced supply chain security Congress envisioned when it enacted the DSCSA ten years ago.”
They continued, saying, “We understand that, although some trading partners are or will be ready to be compliant with the DSCSA by November 27, many will not. This is concerning, particularly for dispensers, because the package-level interoperable data exchange that Congress envisioned under the DSCSA is interdependent on all supply chain trading partners. In other words, the ability of pharmacies and pharmacists to purchase medications from manufacturers and wholesalers is completely reliant on their ability to comply with DSCSA requirements.
“The inability to be ready by November 27 would cause significant risk to patients’ access to their lifesaving medications. If upstream trading partners cannot accurately exchange interoperable package-level data to subsequently provide to dispensers, then the DSCSA is structured to prohibit dispensers from purchasing such product to meet their patients’ needs. This could potentially cause significant harm and drug shortages for patients who rely on these medications.”
