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
Author: Gary Lerner
July 6, 2022
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
May 26, 2021
We Will Be Presenting at This Year’s GS1 Connect Conference
GS1 Connect 2021 Digital Edition: Move Beyond Supply Chain Challenges Date: June 8-10, 2021 (Register by June 3, 2021) Website: https://gs1connect.gs1us.org/ Session 701: An Automated
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
October 23, 2020
FDA Extends Saleable Returns Verification until 2023
FDA is issuing new guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). FDA is concerned that large volume of saleable returns coupled with
June 12, 2019
GS1 Connect 2019: Attaining Interoperability and Overcoming the Challenges
Friday 9:00 AM – 9:30 AM – Healthcare Theater Conference Track: Healthcare Type: Industry Track Sessions Speaker: Gary Lerner, Managing Director, BrandSure, LLC Description: This
August 21, 2017
Defining DSCSA Trading Partners
Today FDA issued draft DSCSA compliance guidance on how to identify DSCSA Trading Partners. This draft guidance provides clarity on how to classify trading partner
July 7, 2017
Unmarked Product to Become Risky
One Year Enforcement Delay – Not!? Hidden Timetable in DSCSA Product Identifier Requirements With about 100 working days left until the November 27, 2017 deadline
June 30, 2017
FDA Proposes 1 Year Enforcement Delay
Product Identifier Requirements would take effect no later than November 27, 2018 June 30, 2017 FDA issues a draft DSCSA compliance guidance delaying enforcement action
November 12, 2015
Interoperability Enables Traceability
Understand the Challenges and Opportunities Pharmaceutical traceability is the new regulatory reality. Within the next five years, most markets will mandate pharmaceutical serialization at the
