I would be willing to bet that almost every regular reader of RxTrace knows who Bob Celeste is, and most of you have probably already heard that he is ending his long tenure with GS1 US. Last fall that organization announced that Bob would continue into the new year as a consultant, and shortly after that, he would transition his GS1 Healthcare US work group facilitation work to others. Bob reminded everyone on his weekly industry calls of that schedule about two weeks ago and by the end of this month he will no longer fill that role.
Companies that participate in the U.S. pharma supply chain and are subject to the U.S. Drug Supply Chain Security Act (DSCSA) are preparing to meet the FDA’s 2015 deadlines for exchanging Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for every shipment. Those preparations include integrating the generation, transmission, confirmation, storage and retrieval (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”) of these documents into their existing supply chain and regulatory compliance processes. It is a big deal and it affects a large number of companies. Continue reading DSCSA Exception Handling: A Preview of Your Next Surprise Headache
The U.S. pharma supply chain will operate under two major phases as dictated by the Drug Supply Chain Security Act (DSCSA). We are now operating under the first major phase. Well, OK, it won’t be fully operational until July 1st when dispensers (see “Who Is A DSCSA Dispenser?”) are required to begin receiving, saving and retrieving Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for each shipment they receive. Drug manufacturers, repackagers and wholesale distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”). But be aware that according to the DSCSA, as of January 1st, all trading partners must be properly licensed and everyone may only buy and sell drugs legally from/to companies who hold a valid State or Federal license. Those and other requirements of the DSCSA were not delayed by the FDA.
The second major phase of the DSCSA will not occur until November 27, 2023 when the law transforms into something that is fairly nebulous right now. That is, between now and Continue reading The Coming Battle Over Decommissioning At The Pharmacy
Before the passage of the Drug Supply Chain Security Act (DSCSA) on November 27, 2013, the pharma industry was focused pretty well on getting the California-mandated serial numbers on 50% of their drug packages by last Thursday (January 1, 2015), and the remainder of their products by next January. But that mandate evaporated by federal preemption as soon as the Federal bill was signed into law. From that moment on, everyone turned their sights toward meeting the data exchange requirements of the DSCSA by last Thursday (see “DQSA: How Should Transaction Data Be Exchanged?”). Of course, just before Christmas, the FDA pushed that effective date out to May 1, 2015 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).
That extension in enforcement is a blessing to a few Continue reading Pharma Industry Attention Returns to Serialization
I happened to be chatting with Bob Celeste of GS1 Healthcare US yesterday at the LogiPharma conference in Princeton, NJ where he was about to speak, when he found out that version 1.1 of their guideline had just been published on their website. The full title of the 137 page document is “IMPLEMENTATION GUIDELINE, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes FOR THE DRUG SUPPLY CHAIN SECURITY ACT AND TRACEABILITY R1.1 — SEP 12, 2014”. You can download a free copy from their web page.
I will have more to say about this document in a few weeks when I have time to review it more fully, but this is the long awaited update that brings the earlier version up-to-date with the Drug Supply Chain Security Act (DSCSA). The 1.0 version of the guideline, published in March of last year, was Continue reading GS1 Healthcare US Publishes Updated Guidance For DSCSA
Last Friday a new committee formed by Rx-360 held their first meeting of parties interested in identifying architectures—or at least “conceptual models”—useful for efficiently meeting the full diversity of pharmaceutical track and trace regulations around the globe. Rx-360 is a non-profit organization “…formed in 2009 to support an industry-wide commitment to ensure patient safety by enhancing quality and authenticity throughout the pharmaceutical supply chain”, according to their press releases.
The new committee is called the “Traceability Data Exchange Architecture Work Group” and it seeks Continue reading Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture
About 3 years ago I published an essay called “U.S. Pharma Supply Chain Complexity” where I attempted to provide a more realistic understanding of the U.S. pharma supply chain than the typical supply chain drawing offers. That essay was aimed at helping the industry select an approach to meeting U.S. state pedigree laws, which are now preempted by the Drug Supply Chain Security Act (DSCSA). But, as with many of my older essays, the underlying ideas still have value despite preemption.
In this case, the ideas also provide a clear explanation for why pharma manufacturers should expect to meet the electronic data exchange requirements that are dictated by the large U.S. wholesale distributors, rather than attempting to get them to accept some alternate approach.
So I have copied and pasted that essay below and then edited to serve this new purpose. Continue reading U.S. Pharma Supply Chain Complexity–Revisited
GS1 just updated their website with the newly updated versions of their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) which were ratified by the GS1 Board on Monday. Both carry the new version number “1.1”. The two standards are separate but intertwined because the core business vocabulary is used within the various EPCIS events, so the two standards are likely to always be updated at the same time, as in this case.
This update marks the culmination of several years worth of hard work by the team, co-chaired by Michele Southall of GS1 US and Andrew Kennedy of FoodLogiQ, facilitated by the great Gena Morgan of GS1 US and with Ken Traub serving as the Editor for both standards documents, under the GS1 Global Standards Management Process (GSMP).
WHY THIS IS SIGNIFICANT FOR THE PHARMA SUPPLY CHAIN
This is a significant event for pharma supply chains around the world, but particularly for Continue reading GS1 Ratifies Updated Versions of EPCIS and CBV