News

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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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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Published FDA-UDI Ruling
September 24, 2013

Published FDA-UDI Ruling

FDA Rule for Unique Device Identification System The Food and Drug Administration (FDA) issued a final rule on October 24, 2013 to establish an identification
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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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Recall of 62 Million Diabetes Test Strips
August 1, 2013

Recall of 62 Million Diabetes Test Strips

The Food and Drug Administration is warning patients with diabetes about the recall of 62 million glucose test strips used to measure blood sugar levels.
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Doctor Pleads Guilty In Misbranded Cancer Drug Case
December 18, 2012

Doctor Pleads Guilty In Misbranded Cancer Drug Case

US Department of Justice convicts two in cases tying counterfeit cancer drugs to Canadian pharmacy business. On November 15th, Dr. William Kincaid, of Johnson City,
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Pharmacy Owner Pleads Guilty
December 18, 2012

Pharmacy Owner Pleads Guilty

Jose Morales Commits $23 Million Health Care Fraud Jose Carlos Morales co-owner of Pharmovisa, Inc. and PharmovisaMD Inc., pleaded guilty to to paying kickbacks and
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