HDA Statement on FDA Enforcement Discretion for the DSCSA’s Final Implementation Requirements

August 25, 2023

The Healthcare Distribution Alliance (HDA) released a statement from President and CEO Chester “Chip” Davis, Jr., on the Food and Drug Administration’s (FDA) announcement that it plans to exercise enforcement discretion for the Drug Supply Chain Security Act’s (DSCSA) final implementation requirements:

“FDA’s determination to exercise enforcement discretion for the DSCSA’s November 27 deadline puts the health and safety of Americans first. While progress has been made among trading partners to reach full implementation, more work remains, and numerous issues are still ongoing. HDA distributor members, in partnership with manufacturers and dispensers, will use the additional time to ensure the ability to send and accept serialized products and the corresponding electronic data fields necessary to fully implement the DSCSA.

“In June, HDA recommended an approach to the final stages of DSCSA implementation to minimize the potential for supply disruptions and interruptions to patient care. Given the state of readiness across the supply chain and the law’s single compliance date for all trading partners, HDA made this proposal to avoid what could become a problematic situation later this year. The agency heard the concerns of distributors, manufacturers and pharmacists and provided guidance that will ultimately minimize the potential for disruptions in the short term. 

“Given the interdependency of the pharmaceutical supply chain, successful implementation of the DSCSA is predicated on all trading partners having systems and procedures tested and ready to go for unit-level serialization. HDA is proud of the collaboration between the public and private sectors as well as FDA that led to the release of this guidance, and we look forward to continuing this work at our upcoming Traceability Seminar.

“Looking ahead, HDA will continue to bring together supply chain partners, FDA and other stakeholders to align on a workable path forward to final implementation. Working together, we can help make sure that the DSCSA is implemented in the manner that Congress intended in 2013 — without undermining the stability of the supply chain on which Americans depend."  

About HDA

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.