Tag Archives: FDA

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 →

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 →

California Pedigree Law

PDUFA Will Not Include RxTEC

June 18, 2012 Dirk Rodgers 4 Comments

Politico.com reported today that the national track and trace addendum that many hoped would be made part of the Prescription Drug User Fee Act (PDUFA) of 2012 was rejected by the U.S. House and Senate Conference Committee. That committee is working on merging the differences between the versions adopted by the two Houses of Congress into a single bill. See “’Track And Trace’ On Ice For Now” in Politico PULSE.

According to Politico, “The word emerged late Sunday night from congressional staffers working on the package who said a last-minute compromise effort failed to win the support of stakeholders, and a decision had been made to drop it — for now.”

Assuming there isn’t a last minute reconsideration, this means that the odds are now slim that a national regulation will preempt the California pedigree law before its effective dates. The remaining chance comes from the fact that the industry is well organized and well represented by the Pharmaceutical Distribution Security Alliance (PDSA) and could decide to back the introduction of a stand-alone bill that contains the essence of the Pharmaceutical Traceability Enhancement Code (RxTEC) language that was part of the PDUFA negotiations, or some other proposal. The success of such an approach likely depends on Continue reading PDUFA Will Not Include RxTEC →

California Pedigree Law

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 →

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 →

RxTrace