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
Last fall the U.S. Congress passed the Food and Drug Administration Safety and Innovation Act, or FDASIA, and the bill was signed into law by President Obama. The purpose of the legislation was primarily to re-authorize user fees that are paid by manufacturers of drugs, medical devices and biologics, but the law also contains quite a few other things. Readers of RxTrace will recall that the well-organized attempt to add a nationwide track & trace requirement to the bill failed (see “PDUFA Will Not Include RxTEC”), but a number of very significant supply chain security elements did make it into the law under the title “Title VII—Drug Supply Chain” (see the full text of the law here). A closer look at these provisions is long overdue. Continue reading The Supply Chain Provisions Of The FDA Safety & Innovation Act
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
Last week I published an essay that gave GS1 some advice on how to trigger interest in adoption of their Global Data Synchronization Network (GDSN). Those of you who read that essay in the first two days read my snarky comments about GS1 seemingly attempting to commandeer the term “Data Quality” to include the need for GDSN. That was based on a mis-interpretation of their marketing materials for their “Data Quality Framework” and as soon as I discovered my mistake I removed that part of the essay, leaving the core point of the essay intact (see “An Open Letter to GS1, RE: GDSN Marketing”).
In fact, GS1 is saying exactly the opposite of what I originally thought regarding Data Quality and GDSN. That is, before you start publishing your supply chain master data (SCMD) through GDSN you should ensure that the quality of your data is high. As GS1 points out, “Good quality data is foundational to collaborative commerce and global data synchronisation.” I couldn’t agree more.
The GS1 Data Quality program is centered on the “Data Quality Framework”, which is Continue reading Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality Program
Any company wishing to make use of GS1 standards—including their barcodes, identifiers and data exchange standards—must first obtain a GS1 Company Prefix, or “GCP”. Normally you would obtain a GCP by applying to the GS1 Member Organization (M.O.) in the country where your company headquarters resides, but if you are a pharmaceutical company that makes drugs for the U.S. market, regardless of where you are located, you will need to obtain a special GCP from GS1 US, the GS1 M.O. in the United States.
That’s because currently, drugs sold into the U.S. market must contain a linear barcode that encodes your U.S. Food and Drug Administration (FDA) National Drug Code (NDC). To properly encode that NDC into a GS1 barcode symbol, you must register with GS1 US the GS1 GCP that matches the FDA-assigned Labeler Code that is a part of every NDC. Only GS1 US can assign/register a GCP that matches your FDA-assigned Labeler Code. I explain all of this in more detail in my essay “Anatomy Of The National Drug Code”.
Companies may end up with more than one GCP over time for several reasons. For example, if a drug company is based in Switzerland, merged with another pharmaceutical company in France a few years ago and sells pharmaceuticals globally, they may end up Continue reading Your GS1 Company Prefix: An Enterprise Resource
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!
For the application of unique serial numbers, or Standard Numerical Identifiers (SNIs), to packages as part of compliance with the California Pedigree Law in 2015-2017 , GS1’s Electronic Product Code (EPC), particularly in barcode form, is the clear winning standard. But there seems to be a very common misconception going around that for pedigree data management, all you need to do to comply with that law is to deploy a system that is based solely on the GS1 Electronic Product Code Information Services (EPCIS) standard. The misconception assumes that there is a formula that can be followed to achieve compliance and that EPCIS is the whole formula.
In truth, EPCIS will almost certainly be an important component in the compliance formula but exactly how it fits, and whether there are other necessary components, has not yet been determined.
There are probably several reasons that this misconception persists. First, GS1 US continues to promote their 2015 “Readiness” Program as if it is that formula. The program documentation strongly implies that, if you simply follow their program, you will “be ready” to comply with the law; but it stops short of actually saying that you will be compliant.
Second, it seems like people are either able to understand the law well but not the technical standards, or they are able to understand the technical standards well but not the law. The legal folks are left to trust what the technical people say about EPCIS, and the technical people assume that as long as the data elements identified in the law are present somewhere then EPCIS must comply.
Now I am not a legal expert but I’ve been looking at the text of the California Pedigree Law for a few years now and I think I understand it at a level that allows me to estimate how various technical approaches might fill its requirements. Let me show you how Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1
Earlier this month the Healthcare Distribution Management Association (HDMA) published newly updated guidance documents for the use of Accredited Standards Committee (ASC) X12 Electronic Document Interchange (EDI) messages in the U.S. healthcare supply chain. This is a very important update that supply chain participants should take notice of because it includes new information about how to properly communicate GS1 identifiers, including GLN’s, GTIN’s, and Electronic Product Codes (EPC’s) like SGTIN’s and SSCC’s, within the four document types that are in common use for Order-to-Cash transactions.
The EDI document types included in the updated guidance includes: Continue reading GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance