The pharmaceutical industry has move toward implementation of the Drug Supply Chain Security Act (DSCSA). At HDA’s 2021 Traceability Online Seminar, Senior Advisor for policy at FDA, Connie Jung, gave an update about enhanced product tracing in 2023. Transaction information will go back to the manufacturers. The product identifier will be required in the TI starting November of 2023 and beyond and will need the following: NDC, Lot number, Serial number and Expiration Date. Trading partners will need to incorporate additional data into the TI and handle product racing information.
The following EDDS activities/protocols effective November 27, 2023, should be in existence: transaction information (TI) and transaction statements (TS) will be exchanged in a secure, interoperable, electronic manner, transaction information must include the product identifier at the package level for each package included in each transaction, the use of aggregation and inference as necessary for verification of product at the package level, systems and processes responding for a product with the TI and TS requested by FDA, systems and processes to provide information of the TI for each transaction with the manufacturer included, and systems and processes to allow acceptable of saleable returns with the TI and TS associated with the product.
All information must be true, accurate, and complete. When handling errors and discrepancies, work with your trading partners to determine the discrepancy and why it occurred while resolving the issue. All handling errors and discrepancies must be resolved immediately because if a product is illegitimate it must be quarantine. The FDA will continue to develop the electronic interoperable system.
The concerns that were brought up during the FDA public meeting were over compliance in 2023. Anita Ducca, SVP for regulatory affairs at HDA had concerns that the EDDS Draft Guidance has inconsistencies with industry’s compliance efforts. Ducca emphasized that HDDA could not support industry-wide adopting of a single, proprietary offering.
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