2019-04-18 | The PDSA's New DSCSA Governance Proposal Explained

On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II...

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2018-03-16 | 3 Important New DSCSA Resources

  

From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.

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2018-02-23 | The 2017 GS1 US Barcode Assessment

Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson.  The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.

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2018-02-19 | Serialization is Only the First Step

Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019.  If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.

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2018-02-12 | The Systech DSCSA Manufacturer Strategy Guide

 

It’s difficult to keep up to date on all the milestones and requirements of the Drug Supply Chain Security Act (DSCSA).  Because the law contains 10 years’ worth of deadlines and detailed requirements for every segment of the supply chain, it’s easy to get lost and miss what your company should be working on now.  Fortunately, most companies need only focus on what is coming up next, while keeping an eye on the long-term requirements.  Toward that end, Systech has just introduced the first...

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2017-11-17 | The HDA Traceability Seminar 2017

The Healthcare Distribution Alliance (HDA) Traceability Seminar is always a great event to find out about the current industry response to the Drug Supply Chain Security Act (DSCSA), and ideas for where it is headed in the future.  This year was particularly valuable for those who attended.  Sessions included a DSCSA update from the FDA, HDA perspectives on DSCSA guidance, manufacturer perspectives on serialization, an update on HDA’s Verification Router Service (VRS) and other technology...

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2017-07-21 | EU FMD and US DSCSA Changes

As the dust settles on the recent FDA news on the DSCSA timeline, I’m sure lots of organisations are wondering what this means to the rest of the world.

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2017-06-16 | DSCSA Resource Guide

Finding information about the Drug Supply Chain Security Act (DSCSA) and how to meet the requirements is difficult.  You need to sift through a lot of information and much of what you find will be out-of-date, biased, or wrong.

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2017-06-09 | Our View: HDA DSCSA Readiness Survey Shows Possible Gaps

The Healthcare Distribution Alliance (HDA) Research Foundation published the results of a DSCSA serialization readiness survey in October of 2016.  The survey was conducted during August and September of 2016.  HDA Research Foundation surveys are particularly credible because the industry organization maintains close relationships with the supply chain departments of most drug manufacturers.  Those responding to the survey take it seriously so they tend to put more time and effort into...

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2017-04-21 | Our View: Strengthening Supply Chain through Standardization

 Pharmaceutical serialization has been around since 2005, with Systech being the first vendor to deliver a solution. The market has grown, and international standards are still varied and complex. Implementations and data constructs vary from vendor to vendor. These factors provide several challenges to businesses' supply chains.

 

 

Efforts are underway to help standardize.

On April 13, 2017, Automation World Senior Editor, Stephanie Neil wrote an article “Strengthening Supply Chain.”  This...

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