Regulations

2018 Traceability Seminar
May 1, 2018

2018 Traceability Seminar

Implementation of the Drug Supply Chain Security Act (DSCSA) continues to transform the pharmaceutical supply chain. As the industry works toward the law’s 2023 finish
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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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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 This draft guidance provides clarity on how to classify trading partner
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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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FDA Seeks UDI Amendment Comments
December 17, 2012

FDA Seeks UDI Amendment Comments

FDA-UDI Comment Period closes December 19, 2012 Last month FDA published an amendment to its July 10, 2012 UDI proposed rule (77 FR 40736). Section
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FDA Issues Proposed UDI Regulation
December 17, 2012

FDA Issues Proposed UDI Regulation

July 3, 2012. In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration proposed that most
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Industry News
December 5, 2012

Industry News

NAFDAC destroys N600m fake drugs in Kano The Punch – Dec 1, 2012 “The seizure and destruction of N600m fake drugs in Kano historic because as a commercial nerve
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