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 →

crimes

InBrief: Pharma Supply Chain Criminals Get Justice

September 24, 2012 Dirk Rodgers 1 Comment

Two weeks ago, confessed pharma supply chain criminal William Rodriguez of South Florida was sentenced to 10 years of prison time, and then two years of supervised release. He was also required to hand over $55 million, which represents the proceeds from his crimes.

What was his crime? He was the person who ran the licensed wholesale drug distribution company formerly in South Carolina, Ocean Pharmed, that bought the Novo Nordisk insulin that was stolen in a cargo theft back in 2009. In his plea, Rodriguez admitted that all of the drugs that Ocean had sold into the supply chain had been obtained from unlicensed or otherwise illegitimate sources, like the stolen insulin.

This is the story that was so well documented by Katherine Eban in her excellent March 2011 article, “Drug Theft Goes Big” in Fortune Magazine online, and which I discussed in my essay “Lessons from ‘Drug Theft Goes Big’” and further Continue reading InBrief: Pharma Supply Chain Criminals Get Justice →

GS1

Should GS1 Continue Developing ePedigree Standards?

September 17, 2012 Dirk Rodgers 2 Comments

For the first time since GS1 produced the Drug Pedigree Messaging Standard (DPMS) standard in 2005, GS1 has just published a call-to-action for the formation of a new standards development group to focus on a new pedigree-related standard. The new group will be called the “Pedigree Security, Choreography and Checking Service (PSCCS) Mission Specific Work Group (MSWG)”. According to the call-to-action:

“This group will develop standards to allow pharmaceutical supply chain parties striving to meet pedigree regulation requirements, by gathering and checking pedigree event data. Standards will also address data confidentiality and security. This MSWG will create

A) standard for security framework applicable to EPCIS and,

B) pedigree checking services.”

This group’s output will not be a self-contained pedigree standard, per se, but Continue reading Should GS1 Continue Developing ePedigree Standards? →

GDSN, UDI

FDA Proposed UDI: The GUDID Database

September 10, 2012 Dirk Rodgers 2 Comments

The FDA is proposing the creation of a Global Unique Device Identification Database (GUDID), a publicly accessible database that would hold information about each medical device marketed in the U.S. The GUDID has some similarities with GS1’s Global Data Synchronization Network (GDSN) but rather than accepting the use of GS1’s standard and service, they appear to have decided to roll their own. Is that a good idea or will it just result in unsynchronized duplication? Is there a way to use GDSN to serve GUDID (or vice versa)? Could the GUDID concept work for drugs too? Continue reading FDA Proposed UDI: The GUDID Database →

Board of Pharmacy

InBrief: California Board of Pharmacy Webcasts

September 5, 2012 Dirk Rodgers

The next meeting of the Enforcement Committee of the California Board of Pharmacy is next Tuesday, September 11, 2012. The Enforcement Committee meetings are where the Board has been discussing issues related to the implementation of the pedigree law. The full agenda for next week’s meeting can be found here, but here is the extract of the pedigree content:

II. Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Medication (10 a.m.)

(a) Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E‐Pedigree Implementation Schedule

(b) Update on the Status of Proposed Regulations to Continue reading InBrief: California Board of Pharmacy Webcasts →

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 →

UDI

FDA Proposed UDI: A Revolution In Number Assignment

August 20, 2012 Dirk Rodgers 1 Comment

Like so many others, I had been patiently awaiting the publication of the U.S. Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) proposed rules. Now that they are out I’ve been studying them and I think I will have enough to say about them that I will cover the topic in a multi-part series. Today I want to look at just one of the differences between the FDA’s proposed UDI rule for medical devices and their National Drug Code (NDC), the pharmaceutical unique identifier. The NDC structure was first conceived by the FDA back in 1969. For more about the history of the NDC see my essay “Anatomy Of The National Drug Code”.

The thing I find fascinating is that at the same time they created the NDC for drugs back in 1969 they also created a comparable identifier for medical devices. They called it the National Health Related Item Code (NHRIC). Both the NDC and the NHRIC were voluntary until 1972 when the FDA made Continue reading FDA Proposed UDI: A Revolution In Number Assignment →

UDI

A Quick Note About The UDI Conference September 18 & 19, 2012

August 17, 2012 Dirk Rodgers 2 Comments

The FDA is co-sponsoring an important two-day conference in Orlando on September 18th and 19th, 2012 that will cover their plans for medical device Unique Device Identification (UDI). Today is the last day to get their early-bird registration rate of $695 so act fast.

But I know a way to get another $100 off of the early, the advance and the standard registration fees. When you register, simply put the letters “RX” in the “Promotional Code” field of the registration form. That lets them know that you are a special RxTrace reader and deserve to pay less. Remember, it works on all registration levels.

I’m going to have a lot more to say about the FDA’s UDI proposed rule in the coming weeks but Continue reading A Quick Note About The UDI Conference September 18 & 19, 2012 →

RxTrace

Yearly Archives: 2012