One of the questions that must be answered is, “how will an ePedigree and track & trace system be funded?”. Who pays, who gets paid, and how much? The answer to these questions are partly determined by which technology model is in use. One reason a distributed model is usually the first model people think … Continue reading Would A U.S. Federal Pedigree Law Require A New UFA?
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 … Continue reading Should GS1 Continue Developing ePedigree Standards?
[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 … Continue reading 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 15, 2010. See “Return Of Two Classics” for an explanation.] In one of my most widely read essays, “RFID is DEAD…At Unit-Level in Pharma”, I pointed out that the choice of serial number carrier technology to be used for compliance … Continue reading Who Will Decide Which Pedigree Model You Will Invest In?
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 … Continue reading The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization
Back in 2007 the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA) and it was signed into law by President Bush. One of the provisions of that law was an instruction to the FDA to “…develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain … Continue reading Should FDA Cede All Standards Development To GS1?
I did not participate in the development of the Pharmaceutical Traceability Enhancement Code (RxTEC), a proposed Congressional bill that was created by the industry lobbying group known as the Pharmaceutical Distribution Security Alliance (PDSA). In fact, while I was aware that a group had been formed last year I wasn’t aware that they were working … Continue reading What If RxTEC Isn’t Adopted?
It has been almost two years since I published “RFID is DEAD…at Unit-Level in Pharma” and we are approaching a pivotal decision by the Food and Drug Administration (FDA) that will determine whether or not RFID will be acceptable for identifying drugs in the U.S. supply chain. Last Thursday was the scheduled final closing of … Continue reading Will the FDA Accept RFID for Drug Identification?
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