DSCSA: Almac update on the US Drug Supply Chain Security Act (DSCSA) business project

October 21, 2024

As you may be aware, the FDA has recently issued an exemption that provides the industry additional time past November 27, 2024 for full compliance with the electronic traceability requirements of the law. However, the FDA has been clear that trading partners must continue to implement processes and systems for electronic data, and exchange data where possible.

We are pleased to announce that Almac has completed all internal process changes and have implemented the use of TraceLink™ for electronic traceability data where it is available. This allows Almac to begin receiving electronic data ahead of schedule and will ensure full compliance with DSCSA.

While Almac strives to minimize the impact that the DSCSA regulation will have on receipts of US commercial prescription medicines, Almac is incurring the cost of the TraceLink™ system utilization and additional processing required to verify electronic data. As a result, to cover these costs, there will be an additional flat fee incurred for any receipt of US commercial prescription drug product where data is received and processed in TraceLink™.

If you have any questions regarding the US Drug Supply Chain Security Act (DSCSA) or how this new regulation could affect US commercial prescription drug products used for your clinical trial, please reach out to your Almac representative.