By Upender Solanki, Managing Director, Americas
The U.S. FDA’s Drug Supply Chain Security Act (DSCSA) Enhanced Drug Distribution Security compliance deadline (November 27, 2023) establishes the requirements to exchange all TI (Transaction Information) and TS (Transaction Statement) in a secure, interoperable and electronic manner. The TI must include the unique product identifier at the package level for all the packages included in the transaction. The DSCSA also requires the Trading Partners to have systems and processes in place to promptly respond with the TI and TS for a product, upon a request by an Authorized Trading Partner or the FDA to support the request for verification or investigation of suspects or illegitimate products.
In the United States, the DSCSA outlines the steps the pharmaceutical industry needs to take to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States1. They will better enable the FDA to protect consumers from counterfeit, stolen, contaminated or otherwise harmful products.
DSCSA Compliance Considerations
There are several aspects one will need to consider when preparing for DSCSA 2023 enhanced traceability milestone. This includes data and the exchange of data between the trading partners, supply chain processes and impacts on them through the introduction of serialization and traceability.
DSCSA requires a trading partner to provide TI to the subsequent owner of a product before or at the time of each transaction. With enhanced traceability, there will be a ton of additional data captured, stored, and exchanged between business partners and multiple disparate systems like packaging lines/site servers, warehouse management systems, ERP etc. The data scope includes master data and transaction data in addition to the serialization and the events data. To avoid any data inconsistency risks and gain business processes execution efficiencies in a serialization and traceability environment, it is crucial to have the other business process execution systems (like ERP or WMS) tightly integrated with the serialization and events repository.
The 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 and determine an onboarding strategy for their partners to electronically exchange TI and TS. At times, onboarding a trading partner may require a lot of effort and time from the kick-off stage, to finally exchanging the real data in production environments. The level 5 serialization network solutions can help get you access to the partners onboarded on the network and can cut the onboarding time and efforts drastically.
Serialization and Traceability change the way the supply chain business processes are executed today, introduce new business processes and also provide process optimization opportunities. For instance, in a serialized warehouse environment, it’s a shift from a scan of an NDC barcode and entering the quantity to ensuring each of the unique product identifiers are validated and captured and change management is so crucial to driving the successful adoption and usage of the change within the business. The businesses will need to ensure they have defined the processes and the systems are in place to support the DSCSA requirements like verification requests from trading partners or government agencies, handling suspect and illegitimate products etc.
The following questions are useful to answer when assessing your DSCSA readiness in terms of IT landscape and processes:
- Have you validated the performance of integrated systems that supports critical business operations like Serialized Warehouse Operations?
- Have you defined the processes to address any verification requests from trading partners or Governmental Agencies and are your systems equipped to support the investigations efficiently?
- Have you defined the processes and are the systems enabled to handle simultaneously – the non-serialized, serialized, and serialized and aggregated products efficiently?
- Have you defined the processes to support the investigation of suspect products and remove the illegitimate product from the supply chain and notify the relevant parties?
- Have you defined the processes and are the systems enabled to handle exceptions?
To get a copy of the complete checklist questions as a PDF you can download it on this link.
How to Prepare for Full-Traceability
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.
SAP Advanced Track & Trace for Pharmaceuticals (ATTP) offers you a secure way to ensure compliance with the DSCSA regulation and has been proven to be the solution of choice for many Fortune 500 pharmaceutical enterprises. Supporting the 14 out of the 20 largest Pharma companies, Movilitas offers SAP roadmap guidance, ATTP solution knowledge and track & trace expertise so that customers benefit from increased supply chain visibility as well as full regulatory compliance. SAP ATTP provides a corporate serialization repository and offers serial number management including regulatory reporting
interfaces. It connects data from multiple pharma stakeholders to simplify compliance and avoid exclusion in key global markets.
While new regulations and laws can be a challenge to understand and then implement compliant technologies, it is not just vital for the FDA to be able to better track the supply chain and products, but there are many benefits to becoming compliant within the industry. These benefits can include improving your company’s reputation and reliability through improved patient safety, new and faster ways to identify illegitimate products in the supply chain and even stronger distributor licensure standards.2
If you need help assessing where you stand in preparation for compliances changes, would like to see a full checklist of must-do items before the November 2023 deadline, or simply want to learn more about how Movilitas can bring you into full compliance, be sure to watch our on-demand DSCSA expert session with Kevan MacKenzie, Upender Solanki and Mark Highhouse. In an interactive conversation, they do a deep dive on the DSCSA 2023 requirements, best practices and a recommendation for the high-level technology architecture.
1 FDA: Drug Supply Chain Security Act DSCSA
2 FDA: Are you ready for the Drug Supply Chain Security Act?