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
InBrief: California Board of Pharmacy Webcasts
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
FDA Proposed UDI: AIDC Requirements
Photo by Nadya Smolskaya
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
FDA Proposed UDI: A Revolution In Number Assignment
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
A Quick Note About The UDI Conference September 18 & 19, 2012
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
Pelotonia 2012…180 Miles!
I missed my self-imposed Monday deadline for an RxTrace essay this week because I am still recovering from the Pelotonia cancer research fundraiser bike ride that I participated in over the weekend. This year I roused the necessary donations, plus my own contributions, to be able to ride the full 180 miles over the two day event.
I have ridden in the Pelotonia since its inception four years ago and I can say beyond a doubt that Continue reading Pelotonia 2012…180 Miles!
Standards and Guidance For U.S. Pharma Supply Chain Technology
[This essay is one of two long lost essays that have now been restored on RxTrace. It was originally published on November 22, 2010. See “Return Of Two Classics” for an explanation.]
In my last essay, “Who Will Decide Which Pedigree Model You Will Invest In?” I pointed out how easy it is to get confused about pedigree technology because of varying claims made by certain companies who have interests that don’t align well with yours. So where can you get better information? I can provide you with a few good sources, and I will also tell you about a missing ingredient that I see in the current guidance landscape that will need to be addressed in the next couple of years. Continue reading Standards and Guidance For U.S. Pharma Supply Chain Technology
InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012
In August 2010 I started an annual estimate of the rise in the percentage of drugs in the U.S. supply chain that will have serial numbers attached. Click here to read my first essay on the topic which explains the concept. Click here to read my 2011 essay. These are not estimates of the actual percentage today. Rather, it is a prediction of the rise from an immeasurably small percentage in early 2010 to 100% at some time in the future. My plan is to Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012
