With the pharmaceutical industry's pivotal role in public health, the Drug Supply Chain Security Act (DSCSA) stands as a safeguard against counterfeit drugs. As the November 27, 2024, deadline looms, stakeholders should actively prepare to meet the stringent DSCSA requirements.
Over 10 years ago, congress passed DSCSA, whose core objectives are to protect consumers from exposure to dangerous drugs, including counterfeits, diverted, stolen, and contaminated medicines, as well as facilitate how the industry manages and executes the drug recall process. This law helps protect the pharmaceutical supply chain and patient safety. The DSCSA mandates traceability, serialization, and enhanced security measures for all stakeholders in the supply chain, including manufacturers, distributors, and dispensers. Pharma serialization providers offer technologies to streamline product serialization processes and traceability.
The Updated DSCSA Deadline - November 27, 2024
In October 2023, the FDA granted the pharmaceutical industry a much-needed enforcement discretion period. The decision to delay DSCSA’s enforcement was made after several stakeholders had expressed concerns over readiness and the need for clarity and flexibility to ensure trading partners can continue to move product through the supply chain when the requirements take effect. The intention is to avoid any impact on the supply of patient medication.
This deadline marks the culmination of years of industry preparation. Non-compliance can lead to severe consequences, including fines, sanctions, and possible criminal charges. The industry must prioritize and focus on adherence to regulations.
DSCSA Implementation Challenges and Solutions
Implementing DSCSA requirements has presented challenges, particularly in technology and infrastructure. Stakeholders are overcoming these hurdles by embracing innovative traceability systems, serialization technologies, and collaborating with respective trading partners within the supply chain.
To successfully meet the November 2024 deadline, trading partners and solutions providers must collaborate in a timely and diligent fashion - and should do so long before the official deadline. Every milestone of DSCSA implementation takes time, and as already experienced during the first phase of DSCSA implementation (LOT level tracking via ASNs), establishing connections between manufacturers (including contract manufacturers and repackagers) and wholesale distributors requires significant efforts, resources, and time.
Compliance and Enforcement
Once DSCSA is in full effect, the FDA, in collaboration with state boards of pharmacy, will closely monitor DSCSA compliance. Stakeholder engagement towards compliance needs to be a top priority. This is not the time to step back, shift priorities or take your time on this project. Organizations have been fined for failing to comply with earlier DSCSA requirements, and there is no reason to believe that will not happen with this last phase of compliance. Achieving compliance is a time-exhaustive process, and one needs to begin as early as possible, if one has yet to start.
Beyond November 2024: Serialization Benefits Abound
Beyond the November 27 deadline, DSCSA compliance will continue to shape the pharmaceutical supply chain as serialization data can provide ample visibility to the supply chain and carry additional benefits beyond compliance. These benefits include better recall initiatives, granular visibility of inventory and goods flow, patient safety and adherence, amongst others. Using serialization, the supply chain can work more efficiently, enable smarter decisions based on hard data, and reduce waste.
With full serialization compliance and interoperability, a wealth of data will become available at all levels of the supply chain. This complex data network will provide many benefits beyond the obvious compliance requirements. This information can be used for both business improvements and patient safety.
Improvements in internal processes will occur organically, including enhancements around product verification and visibility within the supply chain - and eventually down to the patient level. Natural enhancements will likely occur in the drug recall process, including more accurate chargeback and rebate processes. In addition, pharmaceutical suppliers will benefit from a granular view of inventory movement through the supply chain, thus having access to valuable data to better direct sales and manufacturing operations.