Last year, FDA announced a period of “enforcement discretion” related to the deadline for manufacturers to serialize products under the Drug Supply Chain Security Act (DSCSA). As the industry quickly approaches the November 2018 deadline, it is essential for companies to prepare now for the reality of conducting business in a serialized environment. Is your company ready to meet the new requirements?
Serialization and the Role of Master Data
One of the foundations of this new, serialized world is master data. With serialized product in the marketplace, ensuring accurate and consistent master data is critical, and allows those within your distribution channel the ability to reference a reliable data source. Have you updated your trading partners with corresponding GTINs for all your products? If your company is managing this critical information through manual processes, spreadsheets and emails that differ with each trading partner, HDA’s Origin offers a much more efficient and streamlined solution.
Origin: HDA’s Product Data Source
Origin, a high-powered, industry data repository service, allows a company to manage all of its DSCSA-required product information in one place. Users can upload their product GTIN catalog — with GTINs unique for every product packaging size, including individual unit level, bundle, case and homogenous pallet — and rely on Origin to make this information available to direct and indirect trading partners. Information is quickly updated in trading partners’ systems, whether it is an initial upload, new products or communicating package changes, providing users peace of mind about receiving accurate data. There is no need to manage a list of contacts at companies, schedule updates or worry about the needs of unique data formatting for each recipient. Information is available to everyone at one time in an accurate, uniform and consistent way.
For those that use third-party solution providers, they can exchange data with Origin on behalf of manufacturer and distributor clients using an Application Programming Interface. HDA recently announced that Adents is the first solution provider that has entered to meet this certification.
Importantly, Origin also allows trading partners to have a central place to talk about and resolve issues — for example, when a packaging change is made, a new GTIN was assigned and not communicated, packaging sizes have changed or an additional serialized bundle is introduced. Origin’s support team is available to correct mistakes and communicate to all points of contact, minimizing the risk of product quarantine or returns. This means more accurate and clean master data in a single source.
Serialized product is in the supply chain now, and data and product need to match. Accurate master data are necessary to receive product and exchange information. Preparing for deadlines related to saleable returns (2019) and data exchange (2023) will require trading partners to conduct testing and provide feedback to “contributors” (such as manufacturers) — and Origin is an easy tool to update current product information with newly assigned GTINs as well as assist with ongoing maintenance. Manufacturers and repackagers should populate Origin as product identifiers are applied to packages. This will allow participating wholesale distributors to plan and make changes necessary to leverage the GTIN as soon as practical.
Origin currently is built to facilitate easy adoption to meet the short timeline for DSCSA milestones. Moving forward, the vision for Origin expands. Companies will need more robust, global, standards-based master data solutions and Origin will grow with those needs. Future versions will integrate HDA “New Product Form” functionality into the data repository, creating a single electronic way to share both the proprietary data of the full form and the limited operational data elements required for traceability. In addition, Origin has been designed for future compatibility with Global Data Synchronization Standard (GDSN) requirements to ensure that subscribers can evolve from the minimum data required today for U.S. pharmaceutical traceability to the much broader global product data standard.
ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 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 non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.