October 30, 2020
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 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.
July 3, 2020
To attain electronic, interoperable pharmaceutical traceability, each member of the drug supply network must connect and exchange information. Conformance certification ensures consistency among trading partners, aligns data structures, enables common data definitions, and avoids deployment delays.
June 20, 2020
Gary Lerner, Gateway Checker’s president, is featured in a recent Healthcare Packaging article, "3 EPCIS Data Exchange Issues in Pharma Traceability," focusing on how pharmaceutical companies are continuing to make progress to meet the upcoming DSCSA 2023 requirements for unit-level traceability.
June 8, 2020
Join Jeff Denton (AmerisourceBergen) and Gary Lerner (Gateway Checker) as they discuss how to bridge the gap to US Drug traceability at the GS1 Connect Digital Conference, June 16 and 17. GS1 Connect: Bridging the Gap to Pharmaceutical Traceability FDA regulations mandates interoperable, electronic tracing of medicines at the item level to enhance the security […]