Aggregation of saleable drug packages to shipping cases and pallets is not required by the US Drug Supply Chain Security Act (DSCSA) or the EU Falsified Medicines Directive (FMD) or the related Delegated Regulation (EUDR). But certain business processes in the EU under the FMD will be difficult to accomplish without it, and after November 2023, the operation of the supply chain in the US will not be efficient without it (see “Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation”, “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary” and “Pharma Aggregation: How Companies Are Achieving Perfection Today”). Absent a mandate, companies need to recognize, themselves, just how vital aggregation is to their businesses and prepare to generate it and/or make use of it.Continue reading An Aggregation ‘Discussion’
I attended the GS1 US Blockchain Discussion Group kickoff meeting on November 28-29 out of curiosity. Fortunately it was held in Chicago so I didn’t need to travel very far. Just a simple commuter train ride from home each day. Any farther and I might not have attended, but I was glad I did. It was great to have the opportunity to Continue reading GS1 Blockchain Discussion Group Kickoff Meeting
I attended the FDA’s New NDC Format Public Meeting last Monday where I presented my open letter that was last Monday’s RxTrace essay (see “An Open Letter To The FDA: New NDC Format Public Meeting”). After a welcome from Dr. Janet Woodcock, Director, FDA, Center For Drug Evaluation and Research (CDER) and a brief overview of the purpose of the meeting by Paul Loebach of FDA CDER, there were nine presentations from stakeholders and the public. After each presentation, the FDA panel Continue reading FDA New NDC Format Public Meeting
I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar every year because it is where the a very large number of the key members of the US supply chain meet to discuss implementation of the Drug Supply Chain Security Act (DSCSA). Organizations like the HDA, GS1 US and the FDA often save up their significant news and publications throughout the fall so they can release them with big fanfare at this event. This year was no exception. All three of those organizations made news with their announcements this year. Continue reading 2018 HDA Traceability Seminar Recap
I was a little surprised at how heated the discussion was at the breakfast table back during last year’s Healthcare Distribution Alliance (HDA) Traceability Seminar. I chose an open seat at a table with people from multiple drug manufacturers and someone from GS1 US. Our conversation at the table started out typically—the weather, the previous day’s speakers—the usual. I had recently been thinking about the human readable portion of the Product Identifier mandated by the Drug Supply Chain Security Act (DSCSA) (see “The DSCSA Product Identifier On Drug Packages”), so I asked everyone what their company was planning to do? Continue reading Human Readable Text Controversy
Last month GS1 US published the results of an assessment of the implementation progress by drug manufacturers of the Drug Supply Chain Security Act (DSCSA) serialization requirements. It contains troubling indications of the next problem the industry will face in its quest for DSCSA compliance: too many unusable barcodes.
Big deal, you say? That kind of complacency could come back to haunt you later this year. Now is the time to look at your own packages and address any deficiencies. Here is a look at what GS1 US found in their assessment. Continue reading Wholesalers Find Troubling Results In DSCSA Barcode Assessment
Maybe I’m just hyper sensitive to all things blockchain right now, but it sure seemed like the topic of blockchain permeated the sessions and the halls at last week’s GS1 Connect conference, GS1 US’s annual membership event. Oddly, all of the official blockchain content was outside the Healthcare track. The technology is certainly applicable in all industries and apparently there is interest in it outside of the healthcare vertical within GS1 US. But what I observed there leads me to think we are very close to an important tipping point. Continue reading Blockchain Reigns At GS1 Connect 2017