ARLINGTON, Va. – 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 June 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.”
Read the letter in its entirety.
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APhA is the only organization advancing the entire pharmacy profession. APhA represents pharmacists, student pharmacists, and pharmacy technicians in all practice settings, including but not limited to community pharmacies, hospitals, long-term care facilities, specialty pharmacies, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and government facilities. Our members strive to improve medication use, advance patient care, and enhance public health. Visit www.pharmacist.com.
Founded in 1898, the National Community Pharmacists Association is the voice for the community pharmacist, representing over 19,400 pharmacies that employ nearly 240,000 individuals nationwide. Community pharmacies are rooted in the communities where they are located and are among America’s most accessible health care providers. To learn more, visit www.ncpa.org.
NACDS represents traditional drug stores, supermarkets and mass merchants with pharmacies. Chains operate over 40,000 pharmacies, and NACDS’ member companies include regional chains, with a minimum of four stores, and national companies. Chains employ nearly 3 million individuals, including 155,000 pharmacists. They fill over 3 billion prescriptions yearly, and help patients use medicines correctly and safely, while offering innovative services that improve patient health and healthcare affordability. NACDS members also include more than 900 supplier partners and over 70 international members representing 21 countries. Please visit NACDS.org.
