The Preemption Provisions Built Into The California Pedigree Law

June 4, 2012 Dirk Rodgers 10 Comments

In this time of potential Congressional legislative action on drug track and trace I think it is time to take a closer look at the specific provisions contained in the current California pedigree law regarding Federal preemption. As I recall, this language was added in the most recent update of the law, the same update that pushed it out to 2015 – 2017. It is an invitation to the federal government to create their own national pedigree regulation and, if that happens, would cause the California pedigree law to become “inoperative”, thus preempted.

Here is the full text of section 4034.1 from the California Business and Professions Code: Continue reading The Preemption Provisions Built Into The California Pedigree Law →

Data Quality

Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality Program

May 21, 2012 Dirk Rodgers

Last week I published an essay that gave GS1 some advice on how to trigger interest in adoption of their Global Data Synchronization Network (GDSN). Those of you who read that essay in the first two days read my snarky comments about GS1 seemingly attempting to commandeer the term “Data Quality” to include the need for GDSN. That was based on a mis-interpretation of their marketing materials for their “Data Quality Framework” and as soon as I discovered my mistake I removed that part of the essay, leaving the core point of the essay intact (see “An Open Letter to GS1, RE: GDSN Marketing”).

In fact, GS1 is saying exactly the opposite of what I originally thought regarding Data Quality and GDSN. That is, before you start publishing your supply chain master data (SCMD) through GDSN you should ensure that the quality of your data is high. As GS1 points out, “Good quality data is foundational to collaborative commerce and global data synchronisation.” I couldn’t agree more.

The GS1 Data Quality program is centered on the “Data Quality Framework”, which is Continue reading Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality Program →

GDSN

An Open Letter to GS1, RE: GDSN Marketing

May 14, 2012 Dirk Rodgers 5 Comments

Dear GS1,

How have you been? I’ve been fine, done a bit of writing since we last met and gotten a little greyer. How are the kids? My two kids are doing great but I have to admit, after raising two I don’t know how you do it with 125 kids, or whatever the number of M.O.s there are today.

The reason I’m writing to you today is to offer you my thoughts on your Global Data Synchronization Network (GDSN) Marketing campaign. That campaign would be more effective if it focused on demonstrating the distinction between internal master data (and programs associated with improving its quality), and externally shared master data (and the significantly different kinds of programs needed to improve its quality). And especially to show that many (most?) of company master data is, in reality, externally shared master data, either incoming or outgoing. That’s the step that I see missing from your campaign.

Companies who are already familiar with the kind of programs that are designed to improve their internal master data need to be taught to see the special characteristics of Continue reading An Open Letter to GS1, RE: GDSN Marketing →

Sad News

James “Jim” Dowden (1955? – 2012)

May 10, 2012 Dirk Rodgers 5 Comments

I received word last night that our friend Jim Dowden passed away unexpectedly on Saturday. I know many RxTrace readers knew him in one capacity or another. See his obituary here. Most recently Jim was Head of Logistics Management, North America for Genentech. When I first met him back in the mid-2000’s he worked for Hoffman-La Roche and represented them at various industry ePedigree and track & trace meetings. For a period of time I ran into Jim fairly often and we had some great conversations.

As I knew him, Jim was a very open and expressive person who was always ready for a good laugh. He was razor-sharp, quick witted and not afraid to get to the point of the matter. To me, he was fearless and a fun guy to be around. I remember listening in on the webcast of the FDA Track and Trace Workshop last year when Jim’s unmistakable voice came through my speakers during one of the input periods. “When would you like that by?”, he asked rhetorically. The room erupted. Jim had already made the point that many in the room were still trying to formulate in their minds. Classic. Continue reading James “Jim” Dowden (1955? – 2012) →

pharmaceutical supply chain

The Built-in Protections Of The U.S. Pharma Supply Chain

May 7, 2012 Dirk Rodgers 13 Comments

Last week we learned that 11 people were charged with the record-breaking $75 Million drug heist from the Eli Lilly warehouse in Enfield, Connecticut back in March of 2010 (see the excellent article by Jay Weaver in the Miami Herald, including a copy of one of the multiple indictments). Importantly, all of the stolen drugs from the Lilly warehouse were apparently recovered before they could be re-introduced into the legitimate supply chain. But this investigation and the charges go well beyond the infamous Lilly warehouse theft. They include other pharmaceutical, liquor, cigarette and cell phone cargo thefts around the country, allegedly perpetrated by members of the same criminal organization. Cracking this organization could end up disrupting the most prolific source of cargo theft in the United States over the last five years.

Congratulations are due to the law enforcement organizations who contributed to the investigation and to bringing the charges. They include DEA, ATF, FBI, U.S. Attorney of Florida, Miami-Dade Police Department, Florida Highway Patrol, U.S. Attorney of Illinois and U.S. Attorney of New Jersey.

This episode highlights one of the things I call the built-in protections of the U.S. pharmaceutical supply chain—the things that, combined, result in the U.S. having the safest supply chain in the world. In this case, it is strong and cooperative law enforcement organizations. While far from perfect, would you trade our system of justice, including law enforcement, with that of any other country in the world? I don’t think you would (unless you’re one of the Villa brothers or their associates!).

But what are the other components that result in the safest drug supply chain in the world? It’s certainly doesn’t occur by accident, so what are the built-in protections? Continue reading The Built-in Protections Of The U.S. Pharma Supply Chain →

WMS

The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization

April 30, 2012 Dirk Rodgers 2 Comments

Most Warehouse Management Systems (WMS) available on the market today do a fine job of allowing their users to manage inventories in the warehouses of drug manufacturers, distributors and chain drug stores. A WMS is a software system that may be a part of a larger Enterprise Resource Planning (ERP) system, or it may be a third-party application that is interfaced with the owner’s ERP system.

All WMS systems that I am aware of are intended to be sold into multiple industries, not just in pharma. That’s so that the WMS vendor can maximize their sales. The more industries, the more sales and the more profitable it is. Because some industries have long had serial numbers on some of their products (computers and peripheral equipment, cell phones, electronics, medical equipment, appliances, etc.) WMS vendors have included serial number handling in their software for decades. In fact, I would bet that a serial number handling feature was included in WMS systems since the very beginning of that category of software.

However, buyers of WMS systems in the pharma supply chain should be very careful not to confuse a “serial number handling” or even “serialization” checkbox on the WMS vendor’s spec sheets with the kind of “serialization” they will need for compliance with modern pharma serialization regulations. I include Continue reading The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization →

GS1 Company Prefix

Your GS1 Company Prefix: An Enterprise Resource

April 23, 2012 Dirk Rodgers 4 Comments

Any company wishing to make use of GS1 standards—including their barcodes, identifiers and data exchange standards—must first obtain a GS1 Company Prefix, or “GCP”. Normally you would obtain a GCP by applying to the GS1 Member Organization (M.O.) in the country where your company headquarters resides, but if you are a pharmaceutical company that makes drugs for the U.S. market, regardless of where you are located, you will need to obtain a special GCP from GS1 US, the GS1 M.O. in the United States.

That’s because currently, drugs sold into the U.S. market must contain a linear barcode that encodes your U.S. Food and Drug Administration (FDA) National Drug Code (NDC). To properly encode that NDC into a GS1 barcode symbol, you must register with GS1 US the GS1 GCP that matches the FDA-assigned Labeler Code that is a part of every NDC. Only GS1 US can assign/register a GCP that matches your FDA-assigned Labeler Code. I explain all of this in more detail in my essay “Anatomy Of The National Drug Code”.

Companies may end up with more than one GCP over time for several reasons. For example, if a drug company is based in Switzerland, merged with another pharmaceutical company in France a few years ago and sells pharmaceuticals globally, they may end up Continue reading Your GS1 Company Prefix: An Enterprise Resource →

FDA, standards

Should FDA Cede All Standards Development To GS1?

April 16, 2012 Dirk Rodgers 1 Comment

Back in 2007 the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA) and it was signed into law by President Bush. One of the provisions of that law was an instruction to the FDA to “…develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs”, and “…develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.”

The FDA fulfilled these instructions for one of the specific standards that the law identified when the agency published their Standardized Numerical Identifier (SNI) standard back in 2010. That standard was fairly high level and for the vast majority of drugs, use of GS1’s Serialized Global Trade Item Number (SGTIN) (or “GTIN plus serial number”) for drug package identification would comply with it. The text of the FDA’s standard says as much.

By defining the SNI in this way did the FDA surrender the development of the real SNI standard to GS1 (at least the sNDC portion of it)? I don’t think so. In my essay about the SNI standard I described it as the FDA “aligning” with GS1’s SGTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”). Alignment shouldn’t be confused with surrender. The choice of alignment with SGTIN was good for the FDA, good for patients and good for the industry.

WHAT WE GOT WHEN THE FDA ALIGNED THEIR SNI STANDARD WITH GS1’S SGTIN TECHNICAL STANDARD

In the case of the SNI aligning with GS1’s SGTIN we got the following things: Continue reading Should FDA Cede All Standards Development To GS1? →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance