News

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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Finally! Publication of DSCSA Grandfathering Guidelines
November 30, 2017

Finally! Publication of DSCSA Grandfathering Guidelines

The pharmaceutical industry has reason to celebrate. After a 2-year delay, the U.S. Food and Drug Administration (FDA) has published a grandfathering policy, which specifically
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Foodservice Standards Initiative Releases GDSN Guidance
November 29, 2017

Foodservice Standards Initiative Releases GDSN Guidance

June 19, 2017: Over 130 foodservice organizations have banded together to create efficiencies, increase safety and improve quality in the foodservice industry through the Foodservice
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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 This draft guidance provides clarity on how to classify trading partner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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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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FDA Announces DSCSA Enforcement Delay
January 6, 2015

FDA Announces DSCSA Enforcement Delay

Trading Partners Get Early New Year’s Gift As a result of industry pressure, the FDA has delayed enforcement of Drug Supply Chain Security Act (DSCSA)
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HDMA seeks enforcement leniency for DSCSA non-compliance
December 2, 2014

HDMA seeks enforcement leniency for DSCSA non-compliance

HDMA urges FDA to Exercise Enforcement Discretion The Healthcare Distribution Management Association (HDMA) recently wrote the FDA and expressed their concern about the pharmaceutical supply
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