Pharmaceuticals

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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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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Contamination Linked to Indian Deaths
November 19, 2014

Contamination Linked to Indian Deaths

Health officials in India believe that contaminated antibiotics caused the death of more than 13 women and the hospitalization of many more.  According to the
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Using EPCIS to Attain Lot Level Traceability
October 16, 2014

Using EPCIS to Attain Lot Level Traceability

The latest EPCIS Implementation Guideline details how GS1 Standards can best be applied to meet lot-level and item-level traceability requirements as stipulated in the US
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Shortage of Saline Solution may Threaten Hospital Patients
January 23, 2014

Shortage of Saline Solution may Threaten Hospital Patients

The FDA recently warned health care providers of a shortage of saline solution used for intravenous (IV) solutions, such as 0.9% sodium chloride injection.  A
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Drug Supply Chain Security Act Passes
January 23, 2014

Drug Supply Chain Security Act Passes

On the eve of Thanksgiving 2013, a decade’s old struggle to better secure the US drug supply chain was quietly signed into law.  The 113th
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National Track&Trace Legislation Delayed Until After August Recess
August 2, 2013

National Track&Trace Legislation Delayed Until After August Recess

August 2, 2013. (Washington, DC). It was a setback for House committee chairman Fred Upton, who sought to put Pharmaceutical traceability legislation on the president’s
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