HDA Recommends a Phased Approach to Implementing the Final Requirements of the DSCSA
June 20, 2023The Healthcare Distribution Alliance (HDA) is recommending to the Food and Drug Administration (FDA) a phased approach to final implementation of the Drug Supply Chain Security Act (DSCSA) to minimize the potential for supply disruptions and interruptions to patient care. The proposal was communicated through a recent letter to FDA.
In 2013, Congress mandated that all U.S. prescription drug supply chain trading partners meet the DSCSA’s final requirements no later than November 27, 2023. By that date, manufacturers, distributors and dispensers must begin interoperably and electronically exchanging data identifying each prescription drug package purchased and sold. This complex capability to trace at the serialized individual package level does not exist today. Currently, prescription drugs can only be traced at the lot level.
HDA and its distributor members have long supported the DSCSA by investing years of work and millions of dollars to reach the DSCSA’s final requirements. However, given uneven readiness across the supply chain and the DSCSA’s single compliance date for all trading partners, the proposed phased approach is necessary.
“While many trading partners have been diligently preparing for the deadline, some in the community will not be ready to accurately send package-level data to their customers given the complexities of the requirements,” said Patrick Kelly, Executive Vice President, Government Affairs, HDA, in the letter. “This lack of readiness creates serious risks to pharmaceutical supply. If manufacturers cannot interoperably exchange accurate package-level data, the DSCSA would prohibit wholesale distributors and dispensers from lawfully purchasing the prescription drugs needed for patients, which could result in a significant disruption to patient care.”
HDA recommends FDA allow for the DSCSA’s final requirements to be met in phases to build capacity and stabilize these complex processes. The phased approach would include an FDA grant of enforcement discretion limited to certain DSCSA requirements and trading partners, with full implementation phased in over a period of two years. Most importantly, trading partners could continue their day-to-day business operations, avoiding supply chain disruptions and ensuring the safe and secure delivery of medicines to patients.
“We oppose a blanket delay of the DSCSA 2023 requirements for all trading partners and urge this more nuanced approach,” said Kelly. With less than six months from the final DSCSA implementation, HDA asks that the “agency move very swiftly to address these concerns,” asserting that the recommended phased approach “would forestall a potentially significant disruption to the nation’s pharmaceutical supply chain.”
To read more:
Letter to FDA on Recommended Phased Approach to DSCSA Implementation
HDA Comments to FDA on the State of DSCSA Readiness
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.