Tag Archives: RFID

The Federal Lot-Based Pedigree Before Congress

June 3, 2013 Dirk Rodgers 7 Comments

The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”). What is a lot-based pedigree and how is it different from one based on package-level serial numbers? Let’s take a closer look at the kind of system that these bills would require. Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.

First of all, according to both bills, pharma manufacturers would be required to Continue reading The Federal Lot-Based Pedigree Before Congress →

California Pedigree Law

The New Grandfathering Provisions Of The California Pedigree Law

March 4, 2013 Dirk Rodgers 1 Comment

At the February 5, 2013 meeting of the California Board of Pharmacy the Board took the final vote to proceed with filing a number of important clarifying regulations–the first since the Ridley-Thomas bill was enacted in 2008 that established the current staggered effective dates. These include the recognition of the FDA Standardized Numeric Identifier (SNI) as the “unique identifier” for use on each drug package, and definition around how supply chain companies can grandfather their existing non-serialized, non-pedigreed stock at the time the law goes into effect.

The official minutes of the meeting are not yet available but the video has been posted for a few weeks now. The pertinent action occurs in the first video of the two day meeting at approximately 2:24:00 (hours:minutes:seconds). (Don’t you just love government meetings on YouTube?) The source text of the pending regulation (which is Continue reading The New Grandfathering Provisions Of The California Pedigree Law →

California Pedigree Law

“The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance

January 7, 2013 Dirk Rodgers 1 Comment

Currently, we know that companies can use GS1’s Drug Pedigree Messaging Standard (DPMS) to comply with the California pedigree law. That’s been known for a long time now. But many companies have been hoping to use GS1’s more general purpose Electronic Product Code Information Services (EPCIS) standard instead for almost as long. For just as long, it has been known that a number of problems arise when you try to figure out exactly how to apply EPCIS to California compliance.

The problem is, EPCIS was originally envisioned by its creators to share supply chain “visibility” data. That is, event data that was to be collected automatically based on Radio Frequency IDentification (RFID) reads picked up by readers that were to be spread around the supply chain by each of its members. The collection of RFID readers were to form a kind of “visibility” of each RFID tag applied to the products in the supply chain. From this visibility would come benefits. One of those benefits was to be Continue reading “The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance →

Barcodes, RFID

InBrief: RFID and Barcode Interoperability

October 2, 2012 Dirk Rodgers 2 Comments

There is a new and valuable resource available for anyone who needs to make use of both GS1 RFID and GS1 barcodes–or even just one or the other–on any product or shipping container and in any supply chain. It is called “RFID Bar Code Interoperability, GS1 Guideline” and it is available as a free PDF download here on the GS1 website.

This is a guidance document, which means that it isn’t a standard itself but draws contents from GS1 standards documents to better explain the subject. In this particular case it draws primarily from the GS1 General Specifications and the Tag Data Standard. Both of those source documents are huge and so you will find this new guidance document a relative joy to read if you need this kind of information.

Even if you are already familiar with GS1’s RFID and barcode standards, intermingling them so that they are fully interoperable in a single application isn’t Continue reading InBrief: RFID and Barcode Interoperability →

UDI

FDA Proposed UDI: AIDC Requirements

August 27, 2012 Dirk Rodgers 2 Comments

Linear barcodes? 2D barcodes? RFID? Manipulated DNA stands? Microscopic pattern recognition? Mental telepathy? Which Automatic Identification / Data Capture (AIDC) technology(ies) can you expect on the medical devices you buy in the U.S. supply chain in the future? This is the second in a multi-part series of essays examining various aspects of the recently proposed Unique Device Identification (UDI) rule by the U.S. Food and Drug Administration (FDA) (see last week’s essay, “FDA Proposed UDI: A Revolution In Number Assignment”.

The proposed FDA UDI rule requires the use of human readable and at least one AIDC technology to carry the new standardized identifier on all non-exempt devices and/or their packages. An AIDC technology is a way of Continue reading FDA Proposed UDI: AIDC Requirements →

California Pedigree Law

Who Will Decide Which Pedigree Model You Will Invest In?

July 30, 2012 Dirk Rodgers 5 Comments

[This essay is one of two long lost essays that have now been restored on RxTrace. It was originally published on November 15, 2010. See “Return Of Two Classics” for an explanation.]

In one of my most widely read essays, “RFID is DEAD…At Unit-Level in Pharma”, I pointed out that the choice of serial number carrier technology to be used for compliance with the California Pedigree Law would be decided solely by the pharmaceutical manufacturers. I pointed out that most of them would end up choosing 2D barcodes because their ongoing costs for Radio Frequency IDentification (RFID) would be too high.

Since the law doesn’t specify a carrier technology, and because the manufacturers will foot the bill for whatever technology is used, naturally, they get to lead the supply chain in that choice. If you don’t like what they are choosing, then please, step up and pay them to put your preferred carrier technology on their packages. I’m sure the manufacturer’s would put whatever you want to pay for on their packages as long as it would comply with the law.

But what about the pedigree model that the supply chain will use for compliance? Can we apply similar logic to determine who will get to choose the technology that defines what a compliant pedigree is? Yes we can! And here it is. Continue reading Who Will Decide Which Pedigree Model You Will Invest In? →

Aggregation, Inference

Pharma Aggregation: How Companies Are Achieving Perfection Today

March 26, 2012 Dirk Rodgers 7 Comments

Bottle ID photo courtesy of Optel Vision

One of the biggest challenges for companies in the U.S. pharmaceutical supply chain when the California pedigree law becomes operational after December 31, 2014 will be the need to maximize the efficiency of dealing with serial numbers on each drug package. One way to do that is to maximize the use of “inference” where the case serial number is read and the unit package-level serial numbers are “inferred” from the unit-to-case aggregation information supplied by the upstream trading partner (See my essays “Inference in the Pharmaceutical Supply Chain” and “Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!”).

But the problem with the use of inference is that you need to be able to rely on the accuracy of the aggregation information that your supplier provides to you. There is an element of trust in that—not just that you trust your supplier to be truthful with you but that you trust that your supplier’s case packing processes and systems will always accurately capture and document the unit-to-case hierarchy—or “aggregation”. You must be able to trust that the aggregation information your supplier provides to you will be 100% accurate. That’s a lot of trust. Continue reading Pharma Aggregation: How Companies Are Achieving Perfection Today →

Data Carriers

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? →

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