FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain
We will be presenting at this year’s GS1 Connect Conference: An Automated Approach to Drug Traceability Readiness with speaker Gary Lerner, President Gateway Checker Corporation – This presentation will examine enhanced drug distribution security requirements and what it means for industry participants from an information exchange perspective. In short, the enhanced drug distribution security aspect of DSCSA mandates the exchange of a transaction record it each change of ownership.
FDA is concerned that large volume of saleable returns coupled with the challenges of establishing reliable and robust technology may disrupt the distribution of prescription drugs in the United States. FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product. This is a 3-year delay from the current date of enforcement. FDA also does not intend to take action against dispensers who do not verify the product identifiers of suspect product as required by DSCSA before November 27, 2023.