In the United States, the FDA’s Drug Supply Chain Security Act (DSCSA) outlines steps required by the pharmaceuticals industry to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed. The deadline of November 27, 2023, has been implemented to protect consumers from counterfeit, stolen, contaminated or otherwise harmful products. The DSCSA also establishes the requirements to exchange all Transaction Information (TI) and Transaction Statements (TS) in a secure and electronic manner. The TI must include the unique product identifier at the package level for all the packages included within the transaction, including their hierarchies. This information should be kept in case a trace request is initiated by a state authority or the FDA. Aside from the TI/TS exchange, the requirement for manufacturers to respond to verification requests from distributors and dispensers has also been established. Upon request by an Authorized Trading Partner (ATP), the DSCSA also requires trading partners to have systems and processes in place to promptly respond to a verification request for a product.
There are several aspects companies need to consider while preparing for the DSCSA 2023 enhanced traceability milestone. This includes data management, the exchange of data between the trading partners, supply chain processes and the impacts of serialization and traceability.
The DSCSA requires a trading partner to provide TI to the subsequent owner of a product at the time of each transaction. With enhanced traceability, there will be a multitude of additional data captured, stored and exchanged between business partners and systems such as packaging lines and site servers, Enterprise Resource Planning (ERP) and Warehouse Management Systems (WMS). In addition to serialization and events data, the scope includes master and transaction data. To avoid any data inconsistency risks and gain business execution efficiencies in a serialization and traceability environment, it is crucial to have the other business process execution systems tightly integrated with the serialization and events repository.
Trading partners are required to provide an electronic and interoperable TI and TS to the downstream trading partners for each DSCSA-relevant transaction. The pharmaceutical supply chain stakeholder should start with the evaluation of the technical readiness and integration needs of their partner network to determine an onboarding strategy for partner exchanges. At times, onboarding a trading partner may require a lot of effort and time from the kick-off stage to exchange data within production environments. Level 5 serialization network solutions can help companies receive access to partners onboarded on the network and can cut the onboarding time and efforts drastically.
Serialization has changed the way supply chain processes are executed today through the introduction of new systems and providing process optimization opportunities. For instance, in a serialized warehouse environment, there is a shift from scanning National Drug Codes (NDC) and entering the quantity to ensuring each of the unique product identifiers are validated and captured. In this case, change management is crucial to driving the successful adoption and usage of changes within the business. Pharmaceutical companies must ensure they have defined the operations and systems in place to support all DSCSA requirements such as verification requests from authorized trading partners, product identification, and product traceability.
In terms of IT landscapes and operations, the following questions are useful questions to ask yourself when assessing your DSCSA readiness.
While planning for the compliance deadline of November 27, 2023, be sure to review our DSCSA checklist.
With so many changes coming in the very near future, it is key to evaluate now what next steps your company needs to follow until November 2023. Technology will be the driver to ensure compliance and should be selected based on your company and market needs. Supporting the 14 out of the 20 largest pharmaceutical companies, Engineering Industries Excellence offers roadmap guidance, our Movilitas.Cloud solution knowledge and track & trace expertise so customers can benefit from increased supply chain visibility along with full regulatory compliance. Movilitas;Cloud provides a corporate serialization repository and serial number management with reporting, and offers companies a secure way to ensure complete compliance for upcoming DSCSA regulations. Movilitas.Cloud is a top choice solution for pharmaceutical enterprises, enabling easy data-sharing with multiple stakeholders to simplify compliance and avoid exclusion in key global markets.
