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May2014
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503b CompoundingSynergistic Approach to Serialization And The Drug Quality & Security Act
Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to the global dilemma of safeguarding the public from the proliferation of counterfeit drugs, and the Drug Quality and Security Act (DQSA). Now a law, the DQSA includes a phased timeline, extending to 2023, that requires U.S. prescription drug manufacturers to comply […]
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May2014
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503b CompoundingThree Questions To Consider For DQSA Readiness
Last November, after much anticipation, the U.S. pharmaceutical industry saw the enactment of the Drug Quality and Security Act (DQSA), which includes in Title II theDrug Supply Chain Security Act (DSCSA). The DSCSA addresses national pharmaceutical track and trace requirements, and industry stakeholders must now prepare themselves for the first round of deadlines for lot-level […]
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May2014
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503b CompoundingSettlement Seeks $100M Fund for Meningitis Victims
A settlement filed with a federal bankruptcy judge would create a fund of more than $100 million to compensate victims of a nationwide meningitis outbreak linked to a Massachusetts pharmacy, lawyers said on May 6. The outbreak, blamed on a tainted steroid produced by the New England Compounding Center, sickened more than 750 people in […]
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