Monthly Archives: August 2014

Traceability models

Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture

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rx-360-logoLast Friday a new committee formed by Rx-360 held their first meeting of parties interested in identifying architectures—or at least “conceptual models”—useful for efficiently meeting the full diversity of pharmaceutical track and trace regulations around the globe.  Rx-360 is a non-profit organization “…formed in 2009 to support an industry-wide commitment to ensure patient safety by enhancing quality and authenticity throughout the pharmaceutical supply chain”, according to their press releases.

The new committee is called the “Traceability Data Exchange Architecture Work Group” and it seeks Continue reading Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture →

Conferences

2014 Fall Conference Season Preview

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ConferenceIt is time to look at the better healthcare supply chain conferences coming up this fall.  This year the focus will be on the Drug Supply Chain Security Act (DSCSA) and the Unique Device Identification (UDI) final rule implementations.  For the DSCSA I think we will see presentations aimed at both the immediate 2015 data exchange requirements and those aimed at the 2017 serialization requirements, but I also expect to see presentations aimed at “second generation” data exchange—those based on GS1’s recently updated Electronic Product Code Information Services (EPCIS) standard.  After meeting the initial data exchange requirements for Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) in January, companies will need to begin preparing for the second generation using EPCIS (see “DQSA: Getting To Electronic Transaction Data Exchange”).  That transition will likely occur over the next three years. Continue reading 2014 Fall Conference Season Preview →

UDI

FDA Posts Small Entity Compliance Guide For UDI and GUDID

CDRH.CBER.logosYesterday the FDA posted a new document on their website with the title, “Unique Device Identification System: Small Entity Compliance Guide, Guidance for Industry and Food and Drug Administration Staff”.  The document is 23 pages long and it includes an explanation—in what the FDA calls “plain language”—of the FDA’s Unique Device Identification (UDI) system and the Global Unique Device Identification Database (GUDID).  It is aimed at small businesses, but it is a good read for anyone who wants an overview of the regulation.  The guidance contains non-binding recommendations for companies who must meet the UDI final rule, including makers of class III medical devices, which must comply by September 24 of this year.

The document was a requirement under Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996.  That act requires the FDA to Continue reading FDA Posts Small Entity Compliance Guide For UDI and GUDID →

RFID

The Case Against RFID In Pharma

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iStock_000001225482SmallerIt is pretty clear that there is not much interest in the use of Radio Frequency IDentification (RFID) in the pharmaceutical supply chain because every time I publish an essay in RxTrace about some aspect of it, there is a drop in readership.  So at the risk of taking another hit in readership, let’s take a look at the case against the use of RFID in the pharma supply chain.

Back in 2010 I published an essay that really rattled my friends in the RFID vendor community (see “RFID is DEAD…at Unit-Level in Pharma”).  Since that essay was published, the two or three drug companies that were previously shipping drugs with package-level RFID tags on them have ended that practice, replacing the RFID tags with 2D barcodes.  This includes Purdue Pharma and Pfizer, the two flag carriers for RFID in pharma back in the late 2000s Continue reading The Case Against RFID In Pharma →

serialization

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014

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RxTrace.com Serialization Estimate 2014.zoomIt is time for the RxTrace look at the estimated rise in the percentage of drugs in the U.S. supply chain that are serialized.  Every year we take a look at this topic while longingly wishing that someone would perform a real study and publish the numbers.  However, it may not make much difference from here on out because it will be impossible for drugs without serial numbers to exist in the U.S. supply chain in just a few years.  So let’s take a look. Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014 →