Author: Gary Lerner

FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain
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
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We Will Be Presenting at This Year’s GS1 Connect Conference
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
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VRS System Verification at HDA 2020 Traceability Seminar
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
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FDA Extends Saleable Returns Verification until 2023
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
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GS1 Connect 2019: Attaining Interoperability and Overcoming the Challenges
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
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Defining DSCSA Trading Partners
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 This draft guidance provides clarity on how to classify trading partner
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Unmarked Product to Become Risky
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
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FDA Proposes 1 Year Enforcement Delay
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
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Interoperability Enables Traceability
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
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FDA warns Doctors about Risks of Purchasing Unsafe Medications
June 2, 2015

FDA warns Doctors about Risks of Purchasing Unsafe Medications

As of January 1, 2015 the DSCSA mandated that all healthcare practitioners who dispense or administer prescription drugs to patients must purchase their prescription drug
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