The ‘Unique Identifier’ in the EU Delegated Act

The European Commission published a discussion draft of the European Union Delegated Act (EUDA) about two weeks ago (See “Breaking News: The EC Has Published The Delegated Act“).  The EUDA was called for in the Falsified Medicines Directive (FMD) back in 2011 and is primarily intended to define the “safety features” that must appear on most drugs three years after it is finalized.  Assuming it gets finalized around the end of 2015, that means that manufacturers and repackagers targeting the European pharmaceutical market will need to begin placing the specified safety features on their drug packages near the end of 2018.  EU Member States who already have an operational drug tracing law, like Italy and a few others, get an additional six years for companies to switch to the FMD and EUDA on drugs distributed there.

There are a lot of details Continue reading The ‘Unique Identifier’ in the EU Delegated Act

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Wholesaler Confusion Over DSCSA Aggregation Explained

iStock_000028920134XSmallWhile listening to a monthly Drug Supply Chain Security Act (DSCSA) call hosted by one of the Big-3 wholesale distributors I heard a comment that snapped me out of my conference call-induced stupor.  Unfortunately I was in a location where I could not take notes so I don’t remember the exact comments that were made, but I remember what it was that brought me back to full consciousness.

The comment made me realize in a jolt why the Big-3—or at least the one running this monthly call—may be unwilling to give up on their claims that they will need aggregation data to accompany shipments of prescription drugs from manufacturers as early as November 2019.  It may have to do with a mis-interpretation of their handling of saleable returned product within the DSCSA.  Let me explain. Continue reading Wholesaler Confusion Over DSCSA Aggregation Explained

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Breaking News: The EC Has Published The Delegated Act

EC logoPhil Taylor of Securing Industry has scooped me on the publication of the Delegated Act on the safety feature that will eventually be required on all pharmaceutical packaging in the EU.  Well done Phil!  I’ve been traveling too much lately so I missed it until today!  For the details, Continue reading Breaking News: The EC Has Published The Delegated Act

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Stopping Cancer

CancerDeathRatesZoomWe are making progress stopping cancer through research.  We hear about new drugs and therapies on a regular basis, but we have a long way to go.  Lung, prostate and colon-rectal cancers are the most dangerous in men, and lung, breast and colon-rectal cancers are the most dangerous for women, according to the American Cancer Society.

Fortunately, thanks to past research, most people diagnosed with cancer survive at least 5 years, although the survival stats Continue reading Stopping Cancer

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FDA Looking For Consulting Org To Run DSCSA Pilots

FDALogoLast week the FDA quietly posted a Request For Proposal (RFP) on the FedBizOpps.gov government bidding site for a consulting organization to design and implement a program of pilot projects that explore and evaluate methods to enhance the safety and security of the pharma supply chain.  The scope of work is: Continue reading FDA Looking For Consulting Org To Run DSCSA Pilots

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Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015

RxTrace.com Serialization Estimate 2014.zoomIt’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain.  This is an annual look I’ve been doing for five years now.  For my previous essays, see:

In each essay I produced a graph of my own personal estimate Continue reading Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015

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I’ve Changed My Mind, Follow GS1’s HRI Specification

HRI zoomThat’s right, I now recommend that you follow GS1’s Human Readable Interpretation (HRI) specification for drug labeling, even when under a serialization regulation.  Previously I recommended against it (see “The DSCSA Product Identifier On Drug Packages”, and “The ANVISA Unique Medicine Identifier (IUM) on Drug Packages”).  Why have I changed my mind?  GS1 modified their specification to accommodate most of the objections I had over it.  Let me explain.

The new specification for HRI is in the latest version of Continue reading I’ve Changed My Mind, Follow GS1’s HRI Specification

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Your Plain Old Package: Unlock Its Built-in Brand Protection Capability

iStock_000042072924_SmallerWhen serialization of drugs was first being considered for pharmaceuticals back in the mid-2000s, I recall that it seemed to rattle the traditional brand protection vendors who offered package-level authentication technologies.  They were more than a little worried that drug companies would end up using serial numbers in place of their more traditional offerings, like holograms, specialty inks, micro-printing and other technologies.  Back then, some drug companies were looking at using Radio Frequency IDentification (RFID) tags to carry the serial numbers on their drug packaging, and perhaps these vendors feared that they would be left out.

I never understood what all the angst was about.  Continue reading Your Plain Old Package: Unlock Its Built-in Brand Protection Capability

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DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
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