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Who Is A DSCSA Dispenser?

???????????????????????????????????When the U.S. Drug Supply Chain Security Act (DSCSA) was signed into law last November, it introduced a new term into the supply chain lexicon:  “Dispenser”.  It is unfortunate that the authors chose not to use a more recognizable word—like “pharmacies”, or “hospitals”, or “physicians”—because, if they had, more organizations in the dispensing sector might have taken more notice of the requirements they are facing.  But, of course, they could not do that because they wanted to refer to all of those organizations using a single term.  All of those types of organizations fall into the DSCSA definition of “dispensers” and the use of that word appears to have led to some confusion, and therefore some amount of complacency.

“Dispenser” is one of the terms the DSCSA defines so that the rest of the text does not need to repeat the full list of organizations the authors are referring to (see “Don’t Skip The DQSA Definition of Terms Section”).  Its definition is only applicable Read the rest of this essay »

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The HDMA Supply Chain Product Transaction Scenarios For DSCSA

HDMA DSCSA ScenariosBack in the middle of the summer the Healthcare Distribution Management Association (HDMA), the industry association for the primary healthcare distributors in the United States, published on their website a very valuable resource for companies that must meet the U.S. Drug Supply Chain Security Act (DSCSA) beginning in January.  This new resource is tucked away in the HDMA’s “Issues in Distribution”, “Pharmaceutical Traceability” page under the “Technical/Standards” heading [look for “Supply Chain Product Transaction Scenarios: Drug Supply Chain Security Act Implementation (2014)”].  It is free for anyone to download and I highly recommend that you do.  (And while you’re at it, check out some of the other resources available on that page.)

HDMA has been a leader in developing high quality guidance documents that aim to help Read the rest of this essay »

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The “DSCSA Explained”, Now 50% Off

50pc OFFNow, for a limited time, you can download my electronic book that explains the Drug Supply Chain Security Act (DSCSA) for half price!  It’s called, appropriately enough, “The Drug Supply Chain Security Act Explained” by Dirk Rodgers, the founder of RxTrace.  This book will help you make sense out of every section of the DSCSA with thousands of internal hyperlinks embedded in my explanatory text that link you directly to the related DSCSA sections.  You can then easily jump back and forth between my explanation, and the original section I am explaining.  It’s an incredibly easy way to learn the meaning of the text, and the many implications of each section.

You can read the DSCSA on your own, but to get the benefit of my analysis and insights, you will have to get this ebook.  Without “The DSCSA Explained“, you will have difficulty following the stilted language, the many arcane numeric references and the hidden meanings.  I have converted the stilted language into easy to read and easy to understand English.  I have converted those arcane references into English and explain why the DSCSA authors make them. And I have provided my explanation of the hidden meanings and implications to all supply chain parties that are spread throughout the text.  It is an ideal section-by-section guide that will Read the rest of this essay »

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Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited

Exempt signI am working this week, but I know this is a popular time for vacations, especially for those who do not have children in school.  I typically write my Monday essays over the weekend, but because it was a holiday weekend and my wife and I did some leisure traveling, I decided to re-post a popular essay from earlier this year:  “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?“.

I wrote this essay to help companies, large and small, figure out whether or not their products might be exempt from the DSCSA.  In it, I provide a kind of a formula that you can use to determine if a given product is exempt or not.  At least it’s a series of questions or statements that you can ask yourself about your product.  So without further ado,

IS YOUR DRUG EXEMPT FROM THE FEDERAL DRUG SUPPLY CHAIN SECURITY ACT?

Ever since the Drug Quality and Security Act (DQSA) was signed into law last November Read the rest of this essay »

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

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 Read the rest of this essay »

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2014 Fall Conference Season Preview

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. Read the rest of this essay »

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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 Read the rest of this essay »

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The Case Against RFID In Pharma

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 Read the rest of this essay »

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