July 6, 2022
FDA recommends EPCIS for DSCSA Drug Traceability
Happy Independence Day! After many years of uncertainty, FDA has (finally!) recommended that trading partners use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements. Prior regulations and guidance were less specific; only mandating that standards of interoperable exchange “shall comply with a […]
June 5, 2021
Getting Ready: Drug Traceability
Published June 5th, 2021 As the community prepares for the GS1 Connect 2021: Digital Edition conference next week, the FDA issued new guidance to further enhance the security of prescription drugs in the supply chain. This guidance is intended to assist trading partners in complying with the law and achieving a safer, more secure, and […]
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.
