Tag: DSCSA

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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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 This draft guidance provides clarity on how to classify trading partner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 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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