Tag Archives: 2D Barcodes

Will the FDA Accept RFID for Drug Identification?

February 27, 2012 Dirk Rodgers 4 Comments

It has been almost two years since I published “RFID is DEAD…at Unit-Level in Pharma” and we are approaching a pivotal decision by the Food and Drug Administration (FDA) that will determine whether or not RFID will be acceptable for identifying drugs in the U.S. supply chain. Last Thursday was the scheduled final closing of the recent request for comment issued by the FDA formally known as “Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments, 76 Fed. Reg. 66,235” (Oct. 26, 2011) [Docket No. FDA-2011-N-0719].

The closing of this request for comment (RFC) means that it is now time for the FDA to figure out what they might do with the original questions. That is, should they change the requirement for all packages of prescription drugs and many over-the-counter (OTC) drugs in the U.S. to contain the National Drug Code (NDC) encoded into a linear barcode? And if so, what should they replace it with? The RFC doesn’t give any hints about how far they might go and simply asks a series of questions of the industry and interested parties, letting the respondents propose whatever they think the agency should do.

I have spent my Sunday afternoon reading (OK, in some instances, skimming) through all of the responses. They are available for anyone to read (or skim) at http://www.regulations.gov (search for FDA-2011-N-0719). Considering that the input received from this RFC may influence the FDA’s decision about what to replace the linear barcode requirement with, I think Continue reading Will the FDA Accept RFID for Drug Identification? →

Barcodes

Why NOW Is The Time To Move Away From Linear Barcodes

February 13, 2012 Dirk Rodgers 9 Comments

Linear barcodes have served us well for almost half a century, but NOW is the time to move on to something else in the global pharmaceutical supply chain. I think most people already agree with that but I’m not sure everyone fully appreciates exactly why that is. It’s important to fully understand the reason why so that your resolution to move away from linear barcodes is strong and you won’t drag your feet or look back. So let me show you.

SERIALIZATION
THE DAWN OF ^ ~~CIVILIZATION~~

No matter what you might think is going to happen to ePedigree or track & trace regulations going forward, more and more governments around the world are concluding that legitimate pharmaceuticals should come with unique identifiers—serial numbers—attached to them by the manufacturers and repackagers.

Serialization is upon us and I believe that in 10 years the ongoing benefits from it around the globe will significantly exceed the ongoing costs. Whether you agree to the benefits or not you certainly must accede to the fact that Continue reading Why NOW Is The Time To Move Away From Linear Barcodes →

SNI

Anatomy Of An FDA SNI

January 30, 2012 Dirk Rodgers 2 Comments

The U.S. Food and Drug Administration (FDA) published their “Standardized Numerical Identification (SNI) for Prescription Drug Packages – Final Guidance” document almost two years ago (see my essay “FDA Aligns with GS1 SGTIN For SNDC” from back then). The guidance was published as purely non-binding recommendations that reflected the Agency’s current thinking, but in my opinion it is a nice piece of work and can be used as a practical guide, as far as it goes, for implementing drug serialization programs today.

Why is that? It’s because drug manufacturers and repackagers need to serialize all of their prescription drugs that enter the state of California in 2015/2016. Can those companies make use of the FDA’s SNI guidance to comply with the serialization requirements of the California Pedigree Law? I will answer that question in this essay, but first Continue reading Anatomy Of An FDA SNI →

standards

Depicting An NDC Within A GTIN

January 23, 2012 Dirk Rodgers 1 Comment

In recent essays I have covered the “Anatomy of an NDC”, the “Anatomy of a GTIN” and the “Updated HDMA Bar Code Guidance: A Must Read“. Now let’s put them all together. Why would we need to do that? Because the U.S. FDA requires many Over-The-Counter (OTC) and all prescription drugs marketed in the United States to have their National Drug Code (NDC) presented in the form of a linear barcode on the package. Pure and simple. To do that in a way that your trading partners can understand—that is, to do it interoperably—you need to follow a standard. You have two realistic choices for standard approaches to this problem: HIBCC or GS1.

The use of HIBCC standards is fairly common in the U.S. medical surgical devices supply chain but in the pharmaceutical supply chain it is very rare. Most companies choose GS1’s barcode standards so that’s all I’m going to focus on in this essay. If you want more information Continue reading Depicting An NDC Within A GTIN →

HDMA

Updated HDMA Bar Code Guidance: A Must Read

January 9, 2012 Dirk Rodgers 1 Comment

In a long awaited and much anticipated move the Healthcare Distribution Management Association (HDMA) published updated guidance for the formatting, encoding and placement of barcodes in the U.S. pharmaceutical supply chain. The document is called “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain 2011”. The guidance is aimed mostly at pharma manufacturers and repackagers who place barcodes on their drug packages, cases and pallets. The last time the guide was published was in 2005 and this new edition includes some significant changes that everyone in the supply chain who deals with product and shipping container labeling should be aware of.

The updated document can be downloaded from the HDMA Marketplace web page. It is free to HDMA members. Non-members will need to pay a fee but don’t let that stop you from downloading a copy if you have any Continue reading Updated HDMA Bar Code Guidance: A Must Read →

SNI

SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach

June 13, 2011 Dirk Rodgers

I recently published an essay on RxTrace called “Plateaus of Pharma Supply Chain Security” in which I proposed that a better timeline for the introduction of technology to secure the U.S. pharmaceutical supply chain was one based on plateaus. Each succeeding plateau would add the adoption of new technology and/or data communications among the participants in the supply chain with the intent of elevating the security over the previous plateau.

In that essay I included illustrative dates for each of the four plateaus that I offered as an example of the concept, but you could easily imagine the overall program having open-ended dates that would allow the supply chain to adopt one plateau at a time and move to the next plateau only if/when a security problem is discovered at the current plateau. That is, jump to the next plateau only when necessary. Taking this approach, you may never actually need to get to the later plateaus.

For example, imagine that the first plateau were for manufacturers to serialize all drugs at the pharmacy-saleable package level (what I normally call “unit-level”) with an FDA Standardized Numeric Identifier (SNI) and all supply chain owners of drugs were to read the SNI’s and simply keep records of who they bought them from and who they sold them to.

With no data communications between trading partners that includes the SNI’s it might seem that little
security has been gained over what is done today. But this small step (“small” compared to a full pedigree or track & trace system) would allow criminal Continue reading SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach →

Inference

Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!

June 7, 2010 Dirk Rodgers 13 Comments

In an essay published in April, I explained my theory that “RFID is DEAD…at Unit-level in Pharma”, which, if true, would mean that most drugs in the U.S. supply chain would be serialized by manufacturers with 2D barcodes by 2015 for California. In my last essay, “Inference in the Pharmaceutical Supply Chain”, I carried that theory one step further by showing how the widespread reliance on 2D barcodes to serialize at the unit level would lead directly to the widespread use of the practice of inference in the supply chain. This would be out of necessity since the unit-level serial numbers would not be readable without opening their containers, something that can’t happen because it is so inefficient that it would cripple the supply chain. So let me say it this way, the widespread use of 2D barcodes for unit-level serialization will necessitate the widespread reliance on inference. The former leads to the latter just like excessive sunshine leads to sunburn.

But the projections of widespread reliance on inference lead directly to a new concern. Let me explain. Successful use of inference for determining the contents of cases is totally dependent on the accuracy of the aggregation information established and provided by the manufacturer, or whoever packed them. If a packer uses a casepacking process that is incapable of yielding highly accurate aggregation information, inference will not work well.

This is a problem. A big problem, because Continue reading Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not! →

Inference

Inference in the Pharmaceutical Supply Chain

May 24, 2010 Dirk Rodgers 3 Comments

In my recent essay, “RFID is DEAD…at Unit-level in Pharma”, I used relative cost estimates to theorize that Radio Frequency IDentification (RFID) will not be the predominant carrier of serial numbers applied to drug packages for compliance with U.S. pedigree laws. My theory is that there will actually be a mix of RFID and 2D barcodes, and that barcodes will be the predominant carrier technology. As you might expect, that was a little controversial with the RFID industry (See RFID Journal’s blog post in response to my essay). Hey, it’s just a theory. I too, wish everything would be RFID, and for all of the reasons cited by RFID Journal. It’s just that I don’t believe it’s going to turn out that way and that’s based on the logic I laid out in my essay. (Also see FiercePharma Manufacturing’s more neutral post in response to my essay.)

BARCODES WILL PREDOMINATE. LET’S MOVE ON…

In a mixed-but-predominantly-barcode-serialized U.S. pharmaceutical supply chain, companies will not be able to tell which unit serial numbers are inside of each sealed case at receiving or at shipping. Because barcodes are a “line-of-sight” technology, the only way to tell with absolute certainty what the sealed-up unit serial numbers are will be to cut the tape seal, open the case, expose the barcodes, scan each unit and tape the case closed again.

It is a ridiculous notion to believe that Continue reading Inference in the Pharmaceutical Supply Chain →

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