The 2023 DSCSA (Drug Supply Chain Security Act) deadline is quickly approaching, and it is essential that pharmaceutical manufacturers, distributors, and dispensers are prepared for the changes that will come into effect.
The DSCSA States to enhance the security and traceability of pharmaceutical products within the supply chain. It also promotes the use of technology, such as product serialization and electronic information sharing, to improve visibility and accountability in the pharmaceutical supply chain. It aims to prevent the distribution of counterfeit, adulterated, or otherwise unsafe drugs and to ensure that patients receive authentic medications.
When Will This Take Effect?
Beginning in November 2023, all prescription drugs in the United States must have a unique product identifier (UPI) on their packaging. The UPI will enable the tracking of drugs from the manufacturer to the dispenser, ensuring that counterfeit or contaminated drugs do not enter the supply chain. In addition to UPIs, the DSCSA requires that manufacturers, distributors, and dispensers maintain a product tracing system that records the transaction history and the chain of custody for each drug product. This information must be kept for six years and provided to the FDA upon request. Failure to comply with the DSCSA could result in severe penalties, including fines and criminal charges.
To ensure compliance, companies should begin implementing changes now and work closely with their supply chain partners to ensure that they are also compliant.
Mastering Compliance: Unleashing NetSuite's DSCSA Solution!
NetSuite, a cloud-based ERP (Enterprise Resource Planning) software, can help pharmaceutical companies achieve compliance with the 2023 DSCSA requirements. NetSuite provides a comprehensive solution for managing the supply chain, including inventory management, order management, and financial management. It can help pharmaceutical companies implement the necessary changes required by the DSCSA, including the UPI. NetSuite can traceability and manage the UPI at each stage of the supply chain, from the manufacturer to the dispenser, ensuring compliance with the new regulations.
In addition, NetSuite's product tracing system can help pharmaceutical companies maintain the transaction history and the chain of custody for each drug product, as required by the DSCSA. It can also generate reports and provide real-time visibility into the supply chain, helping companies to identify any potential issues and quickly take corrective action. The platform can be customized to meet the specific needs of each company, providing a personalized solution that can adapt to changing business requirements.
With NetSuite, pharmaceutical companies can ensure the safety and security of the drug supply chain, protect patient health, and avoid penalties for non-compliance. By leveraging NetSuite's robust features and functionalities, companies can effectively track and trace their products from manufacturer to end-user, ensuring complete transparency and accountability.
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