DSCSA stands for Drug Supply Chain Security Act.
The DSCSA outlines requirements for manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers (trading partners). The DSCSA is intended to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.
The requirements, the development of standards and the system for product tracing have been in place since 2015 and are to be continued until 2023.
Intracompany distributions – Distribution among hospitals under common control – Public health emergencies – Dispensed pursuant to a prescription – Product sample distribution – Blood and blood components for transfusion – Minimal quantities by a licensed pharmacy to a licensed practitioner – Certain activities by charitable organizations – Distributions pursuant to a merger or sale – Certain combination products – Certain medical kits – Certain IV products – Medical gas distribution – Approved animal drugs
The new requirements make it extremely easy to rework packages, meaning that all necessary and important information about the medications will be accessible when scanning the parent. This saves an enormous amount of time, as it will no longer be necessary to open each container to scan each individual child. Since all the data is easily accessible, tracking products throughout the supply chain becomes much easier, and the entire distribution system becomes more efficient, secure and trustworthy.
Not complying with the DSCSA can lead to fines, suspension or revocation of license, and even civil penalties or imprisonment.