Tag Archives: GTIN

The Future of Healthcare Supply Chain Security

March 3, 2014 Dirk Rodgers 2 Comments

Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:

In the U.S.:
In the E.U.:
- The Falsified Medicines Act (FMA)
- The Harmonized Unique Device Identification Framework
- The anticipated Delegated Acts related to the FMA

Continue reading The Future of Healthcare Supply Chain Security →

serialization

Will Generic Drug Manufacturers Serialize Their Drugs In Time?

July 9, 2013 Dirk Rodgers 2 Comments

The one thing all pharmaceutical manufacturers can count on, regardless of whether or not the U.S. Congress passes a new track and trace regulation in this or future sessions, is that unit-level serialization will be a necessity on drug packages sold into the U.S. market within the next few years. We have all been paying close attention to the draft legislation that has been moving through the two houses of Congress for several months now, but there is no doubt that unit-level serialization will be required whether something passes at the federal level or not. The only questions are, exactly which year will it be required and what else will be required?

We know that Continue reading Will Generic Drug Manufacturers Serialize Their Drugs In Time? →

Inference

California’s Draft Inference Regulation

April 23, 2013 Dirk Rodgers

Yesterday I published an essay about the new discussion draft of a Federal track and trace regulation bill from the Senate HELP Committee. It is definitely worth watching closely, but don’t let it take your eye off of the California regulations. Those are real today and will move forward unless Congress and the President complete the enactment of a bill that preempts the California law. That’s a long and uncertain road and the discussion draft released last week is only the first unofficial step.

Last week I wrote about the new draft regulation on certifications in California e-pedigrees. In the same document—distributed by Joshua Room, Supervising Deputy Attorney General, California Department of Justice assigned to the California Board of Pharmacy, at the March 14, 2013 Enforcement Committee meeting (and converted to MS Word document form by me)—on page 3, you will find the draft regulation for the use of inference. This draft regulation is Continue reading California’s Draft Inference Regulation →

pedigree certification

Draft Regulations On Certifications Within California ePedigrees

April 15, 2013 Dirk Rodgers

During the March 14, 2013 meeting of the Enforcement Committee of the California Board of Pharmacy, Joshua Room, Supervising Deputy Attorney General at California Department of Justice assigned to the California Board of Pharmacy distributed copies of draft text that he is looking for public comments on. The draft is for regulations covering pedigree “certification”, the use of “inference” and “inspection” of electronic pedigrees. Unfortunately the text is Continue reading Draft Regulations On Certifications Within California ePedigrees →

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 →

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? →

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 →

RxTrace