Author: Gary Lerner

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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Know Your Source
June 2, 2015

Know Your Source

Doctors, nurses, purchasing agents, pharmacists, office managers and other health care professionals are being warned by the FDA to Know Your Source. The FDA is
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Establishing Supply Network Visibility
May 27, 2015

Establishing Supply Network Visibility

Using serialized information to Gain Compliance and Add Business Value All pharmaceutical manufacturers with prescription drugs destined for the United States market must address the
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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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FDA DSCSA Standards for Interoperable Exchange
December 2, 2014

FDA DSCSA Standards for Interoperable Exchange

Things to Know: Standards for Interoperable Exchange FDA met its DSCSA mandate by publishing a Draft Guidance, “Standards for the Interoperable Exchange of Information for
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New System to Improve US Drug Security?
December 1, 2014

New System to Improve US Drug Security?

FDA Publishes DSCSA Standards for Interoperable Exchange To prevent dangerous drugs from reaching consumers, the FDA knows a new system is necessary to identify and
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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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