It's been nearly 10 years since congress enacted the Drug Supply Chain Security Act (DSCSA) in efforts of strengthening the traceability of drugs as they move through the supply chain. The mandates requires trading partners exchange and verify product identifier information at the package level, allowing end-to-end tracking of every item sold throughout the distribution chain. As we approach the finals steps of this 10 year implementation, which will go into effect on November 27th, 2023, the FDA has provided multiple opportunities to allow supply chain stakeholders to voice their opinions:
On December 7-8, 2022, the FDA held a virtual public meeting allowing supply chain stakeholders an opportunity to share their perspectives on DSCSA’s enhanced drug distribution security requirements.
Most recently, the FDA is now requesting comments on the virtual public meeting "DSCSA Implementation and Readiness Efforts for 2023", in an attempt to gather a general perspective from a wider audience. Comments, electronic or written, must be submitted by February 6, 2023.
Now is the time to start preparing, as failure to comply can result in significant penalties from the FDA. REAL Solutions Group offers a multitude of services to help you stay compliant, including our HealthRISC subscription - a customizable reporting service engineered to meet your regulatory and policy tracking needs. Speak with an industry expert at REAL Solutions Group (RSG), to learn more about how we can guide you through the complexities of the DSCSA requirements to ensure you are ready for November 2023.
Resources:
Meeting information & event materials: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa-implementation-and-readiness-efforts-2023-12072022