Last week, Systech participated in the FDA DSCSA Pubic Meeting, held in Silver Spring, MD at FDA headquarters. The meeting was two days long and was aimed at discussing the possible characteristics of the Enhanced Drug Distribution Security (EDDS) phase under the Drug Supply Chain Security Act (DSCSA) beginning in November of 2023. The meeting was broken down into four primary topics:
- Standards for Data Exchange
- Data Architecture
- Aggregation and Inference, and
- 2023 Scenario Exercises
Each session started with an introduction to the topic by the FDA, followed by guest speakers, followed by a breakout session, and ended with a report-out and large group discussion of the topic. Our own Global Regulatory Strategist, Dirk Rodgers, spoke during the first section. Standards being discussed for data exchange included OPEN-SCS and EPCIS—both of which are supported by Systech products.
Data architecture refers to the arrangement and location of data necessary to meet the interoperable supply chain-wide traceability requirements of the EDDS. After the prior FDA Public Meeting in August, the FDA recognized that the industry does not want a centralized data architecture, but favors a distributed, or de-centralized model instead. Speakers were from GS1 US, who spoke about their Global Data Synchronization Network (GDSN), the Healthcare Distribution Alliance (HDA), who spoke about their Verification Router Service (VRS), the National Council for Prescription Drug Programs (NCPDP), who spoke about dispenser issues with the DSCSA, and the Center for Supply Chain Studies, who spoke about the application of blockchain technology for DSCSA.
Aggregation is data that describes the parent-child relationships between serialized units and higher-level collections, like bundles, cases and pallets. Inference is a business process where the unit serial numbers are “inferred” from the serial number of one of the higher-level collections through the application of the aggregation data. The accuracy of the inference process is only as accurate as the aggregation data collected. The industry wants to use aggregation and inference to help streamline the operation of the supply chain within the EDDS, but the FDA is concerned with the expected accuracy. Aggregation data is known to have accuracies that are something less than 100% when measured over lot-level quantities and depending on the technology used to help collect it. Systech’s aggregation solutions can be applied to a wide range of technical approaches to meet the needs and preferences of our customers.
The final section was what the FDA called “2023 Scenario Exercises”. These scenarios were designed to explore a range of situations that will occur after the EDDS phase begins. Attendees were encouraged to apply different technical approaches to EDDS operation to discover how each scenario would be met and what problems might arise. These included cargo theft, saleable returns, errors in aggregation and inference, and suspect product investigations.
FDA Public Meetings are just one of the sources of information we use to help us keep our Systech Global Serialization Regulatory Update documents up-to-date every quarter. These meetings offer a wealth of knowledge to those who attend them. And we do attend, whenever they hold them.