Last week the European Medicines Verification Organisation (EMVO) sent a letter to all of their “Onboarding Partners” (OBPs), or drug marketing authorisation holders (MAHs) informing them of a problem EMVO is seeing with many of the expiration dates on drugs being uploaded. The problem they highlighted in the letter has been recognized by people around the world, and each country has decided to handle it slightly differently. Drug manufacturers should be aware of these differences to ensure compliance and avoid false failed verifications. Let’s take a closer look at the issue and what each country expects you to do about it.Continue reading Global Differences In Expiration Date Encoding
There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline: the September 24, 2014 deadline for UDI on class III medical devices.
The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:
- The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
- Dates on the labels of these devices must be formatted as required by § 801.18.
- Data for these devices must be submitted to the Global Unique Device Identifier Database (GUDID). § 830.300.
- A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
- Class III stand-alone software must provide its UDI as required by § 801.50(b).
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 and click here to read my 2012 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 was to Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013
The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee released a new discussion draft last Friday of a bill that would preempt all state pharmaceutical ePedigree laws and establish a pathway toward a nationwide track & trace regulation. Take careful note of this one. It could be the one that finally makes it. Let me explain. Continue reading The New Pharma Track & Trace Discussion Draft In The Senate
GS1 Healthcare US, an arm of GS1 US the member organization (MO) of the global GS1 standards organization, has just published the “preliminary version” of a track & trace implementation guide. The full title is “Implementation Guideline, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes To Support Pedigree And Track & Trace, Release 1.0”.
This document contains the accumulation of thought and best practices generated over the last nine years within various working groups of GS1 Healthcare US and from pilots conducted by its members (including the Abbott Labs, McKesson, VA and GHX pilot that I wrote about in “The Significance of the Abbott, McKesson and VA Pilot”). Pulling it all together into a single coherent document turned out to Continue reading The New GS1 Healthcare US Track & Trace Guidance
The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same. You really can’t get away with using only a single GS1 standard. That’s why they are sometimes referred to as “The GS1 System of Standards“. It’s a “system” of standards. Multiple standards that are designed to work for you together in concert; as a whole; not independently.
So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”). Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN: Continue reading GS1 Standards – Betcha Can’t Use Just One!
I want to thank everyone for reading and commenting on RxTrace in 2010 and wish you all HAPPY HOLIDAYS and a HAPPY NEW YEAR. Due to our family party schedule I don’t expect to post any more essays this year.
I’m planning to see a number of movies in the next few weeks with my wife, two daughters and son-in-law. One of our favorite holiday activities is to debate which ones to see. Debating with my kids is probably what it must be like debating with me, but in the end we all have fun and always have a lot to talk about (and Dad pays).
So drive carefully, don’t drink and drive and don’t eat too much. On the other hand, do make peace with your family members, sing a lot, say thanks to members of our armed forces and give to charity. And, OK, you can eat too much just once.
See you next year.
I’m pretty excited about the kickoff this Wednesday of the GS1 EPCglobal Software Action Group (SAG) Discovery Services Work Group which will take the business and technical requirements that were collected by an earlier group and turn them into an actual standard. This will be the first new major technical standard GS1 has started for quite a few years. The most recent kickoff I can remember was the GS1 Drug Pedigree Messaging Standard (DPMS) which kicked off back in late 2005 and completed in January 2007. The GS1 Electronic Product Code Information Services (EPCIS) standard effort kicked off in late 2004 and completed in April 2007. That gives you an idea of how long these things take.
The effort to create the business and technical requirements for Discovery Services started just about two years ago and completed this past December. How long will it take to get to a ratified standard? The GS1 Discovery Services Work Group Charter predicts it will be done in June of 2011, but predictions in charter documents are notoriously optimistic. The EPCIS Charter predicted that standard would be ratified in August of 2005, for example—one third the time it actually took.
This is not a bad thing in my opinion. A Charter document needs to estimate how long the effort will take, but once things get rolling, GS1 EPCglobal takes as long as needed to get the standard right. So how long will this one take? Based on how long the requirements took, I’m guessing Continue reading Will The Pharma Supply Chain Find Any Value In GS1 Discovery Services?