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.
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.
July 3, 2020
Methods to Ensure EPCIS Drug Traceability Standards
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 16, 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.
