The DSCSA Stabilization Period Deferred the Enforcement of 3 Key Dispenser Requirements:
- Package-Level Verification Against EPCIS
Note: Product Verification is a current requirement that is enforceable. This can be completed manually, or via barcode scan. Only Verification of Transaction Data against EPCIS, has been deferred. - Participation in Interoperable Electronic Data Exchange (Track and Trace)
Come November 2024, trading partners will be required to participate in an interoperable electronic data exchange to respond to audits and inquiries, file 3911s in the event of illegitimate or suspect product, and to exchange tracking and tracing information when transferring ownership of product. - Documented Processes to Manage Salable Returns
It is critical to have your standard practices documented in order to remain compliant with DSCSA. This will be the first line of questioning in the event of an audit. You should already be having internal discussions documenting internal policy and procedure for DSCSA Compliance; including: Suspect and Illegitimate Product, Quarantine Controls, and Recall Response, in addition to the soon to be required Salable Returns Process.
These requirements above become enforceable on Nov 27, 2024. The FDA urges all trading partners to use this period to ensure their readiness to meet 2024 requirements. Audits on enforceable requirements are already underway.
Looking for all of the Current Dispenser Requirements? Click Here.
