June 4, 2021
Enhanced Drug Distribution Security at the Package Level under DSCSA
Published June 4th, 2021 On June 3rd, 2021, the FDA provided new guidance to further enhance the security of prescription drugs in the U.S. supply chain. To help stakeholders understand the emerging DSCSA requirements FDA published four guidance documents to assist trading partners in complying with the law and achieving a safer, more secure, and […]
June 3, 2021
FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain
June 03, 2021 The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research “Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate […]
May 26, 2021
We Will Be Presenting at This Year’s GS1 Connect Conference
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.
October 30, 2020
VRS System Verification at HDA 2020 Traceability Seminar
As you know, the FDA recently extended saleable returns verification until 2023. Please join Gateway Checker CEO and Founder Gary Lerner at the HDA 2020 Virtual Traceability Seminar where he is hosting a VRS System Verification roundtable on Tuesday, November 3 at 10:00 AM ET. We will address the FDA’s saleable returns verification extension and […]
October 23, 2020
FDA Extends Saleable Returns Verification Until 2023
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.
