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.
July 3, 2020
How to Ensure Conformance to EPCIS Standards in Drug Traceability
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
EPCIS Data Exchange Issues in Pharma Traceability
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
GS1 Connect – Bridging the Gap
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 […]
June 8, 2020
Gateway Checker’s Gary Lerner to Discuss Pharmaceutical Traceability at GS1 Connect
Gary Lerner, president and founder of Gateway Checker and expert on supply chain integrity, will be discussing the future of pharmaceutical traceability at the GS1 Connect virtual conference, taking place June 16-17, 2020. Gary, together with Jeff Denton of AmerisourceBergen, will present “Bridging the Gap to Pharmaceutical Traceability” as an On Demand session, which will […]
