Prioritizing DSCSA Adherence to Protect Patient Safety
Matthew Sample, SVP, Manufacturer and Replenishment Operations, Cencora (formerly AmerisourceBergen)
On August 25, the U.S. Food and Drug Administration (FDA) announced that it will delay its enforcement of the Drug Supply Chain Security Act (DSCSA) until November 2024, providing manufacturers, distributors, dispensers and other trading partners a year-long “stabilization period” to comply with the new regulations.
Introduced nearly a decade ago, the DSCSA requires all pharmaceutical products to have a unique serial number that will track data about their every movement, a measure that promises to strengthen the U.S. supply chain and protect health care providers and patients from counterfeit, unapproved, or potentially dangerous drugs.
The DSCSA requires substantial changes to the processes and protocols used by manufacturers and their trading partners and while there has been extensive progress made to date there remains significant concerns around the industry’s readiness and alignment in adhering to the new regulatory landscape (even with this latest delay). As the FDA noted in its decision to delay enforcement, implementing DSCSA to meet the original deadline, in November 2023, could have resulted in drastic implications to the supply chain, including significant quarantined products sent for regulatory reviews, ultimately risking delayed patient access to life-saving medications.
The Dangers of Delaying
Cencora commends the FDA’s decision because the additional 1-year stabilization period will help prevent risks to the supply chain. However, an extra year shouldn’t encourage partners to postpone implementing necessary changes to meet the new deadline. In fact, the FDA explicitly leaves room in its guidance to selectively enforce requirements on partners who have not demonstrated incremental progress towards compliance.
Deferred enforcement of the DSCSA has, over time, stagnated implementation of critical milestones, including enhanced DSCSA data exchange, i.e. “serialized data”. For example, out of more than 500 manufacturers, more than half have not started sending ANY data for the upcoming November 27th, 2023 deadline. Even more worrisome, among the manufacturers sending data, about 30-35% of their shipments are arriving with no DSCSA data.
If these trends were to hold once the DSCSA is fully implemented, approximately a third of all medications received would need to be quarantined, due to non-compliance, causing significant delays in getting treatments to the patients who need them. Across Cencora alone, we move approximately 1+ billion units of medications per year. With DSCSA, a piece of data must identify each of these 1+ billion products. If that data is not with the medication, the product doesn’t move, and creates more bottlenecks and delays in reaching patients.
Safeguarding Patient Wellbeing
To ensure the DSCSA is successful – which will mean that medications reach patients in a timely and safe manner – collaboration throughout the entire supply chain is critical. The 1-year stabilization period offers a unique opportunity that will allow for data testing and sufficient time to ensure data storage solutions and onboarding requirements are met. We encourage trading partners to use the delay to align with their counterparts on overall readiness and troubleshoot any issues while allowing systems and processes to mature and scale by November 2024.
Since the DSCSA’s introduction 10 years ago, Cencora has remained steadfast in our commitment to ensuring a smooth transition to its requirements. Diligently, we have allocated substantial time, resources and financial investments towards the deployment of technology and processes that safeguard authenticity and trackability for all pharmaceutical products that move through our systems, so that no medication is unaccounted for.
We continue to stay at the ready to support our partners to meet DSCSA requirements through the stabilization period, and encourage ongoing proactive measures to ensure compliance before the November 2024 deadline approaches.
Additional details on DSCSA, and how Cencora can help, are below: