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’
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
At a recent GS1 discussion group meeting one of the moderators acknowledged that they need to create a clear explanation for exactly what EPCIS is. I’ve never been very impressed with GS1’s ability to explain their own standards at a high-level for non-technical readers. They do a great job of explaining them at the minutia-level, but that’s the problem. Non-technical people who must make decisions about GS1 standards probably get bogged down in that minutia and end up not really understanding what it is, why it is significant, and why they should use it. Too much technical documentation exists on how to apply EPCIS, and not enough documentation on the why.Continue reading EPCIS Explained
There are a lot of discussions going on in the industry right now, over which approach and which technologies the US pharma supply chain should select to meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA). People are understandably confused over these discussions. Why should we guess what the FDA will accept in 2023? Blockchain? EPCIS? Aren’t these debates and discussions just a waste of our time? Why doesn’t the FDA just tell us which technology they will accept for the DSCSA in 2023? In fact, these questions have become so common lately that I think it is time to examine what is going on. There are definitive answers to these questions, and they are contained within the DSCSA itself. Continue reading DSCSA: Why FDA Will Not Mandate Blockchain, EPCIS Or Any Other Specific Technology
The lack of simple, standard, low cost product master data synchronization threatens to derail the industry’s general consensus-plan to use GS1’s Electronic Product Code Information Services (EPCIS) as the basis of the interoperable electronic data exchange to meet the 2023 requirements of the Drug Supply Chain Security Act (DSCSA) (see “HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS”). This is probably why the Healthcare Distribution Alliance (HDA) tried to get out in front and offer their Origin master data synchronization service last year (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”). And it likely underlies why TraceLink filed a lawsuit against HDA a few months later (see “Tracelink vs. HDA” and “What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data”, and also see the standard disclaimer below). That lawsuit has since been settled out of court.
Without everyone holding the identical product master data for every drug they might receive, EPCIS messages used to document DSCSA transactions will need to carry that master data. That would induce a heavy Continue reading Simple, Standard, Low Cost Product Master Data Synchronization for DSCSA
That’s right. I have now concluded that Blockchain will never be used in the US supply chain to fulfill the DSCSA requirement for sellers to provide buyers with Transaction Information (TI) and Transaction Statements (TS) (see also “Could Blockchain Technology Be Used For DSCSA Compliance?”). So if you are currently planning to do a pilot to test a proposed architecture to do that, I recommend that you adjust it to test something else (see also “What Should FDA Pilot?”).
In fact, the thing to test is whether or not it can be used to facilitate gathering the TIs for a given Standardized Numerical Identifier (SNI) going back to the original manufacturer, as needed after November 27, 2023 during a suspect product investigation or recall. Those are rare events compared with the number of drug sales and shipments where the TI and TS will need to be exchanged.
How and why did I come to this conclusion? Let me explain. Continue reading Blockchain Will Not Be Used For DSCSA Data Exchange
Once again, the Healthcare Distribution Alliance (HDA) has submitted written comments to the FDA as a follow-up to the FDA’s most recent DSCSA Public Meeting held on December 5-6 (see “HDA Schools FDA On DSCSA”, and “FDA DSCSA Public Meeting #2, Still A Gulf”). The comments cover seven “issues” HDA wanted to provide further comments on, beyond those already expressed in the public meeting itself and earlier written comments. The seven issues include:
- “HDA urges greater appreciation for and recognition of the ‘distributed model’…”
- “HDA recommends topics to address at the February 28 public meeting”
- “We expand upon certain data standard and exchange issues from the December public meeting”
- “…we offer suggestions for where ‘guardrails’ may be useful [to the industry]”
- “We summarize our understanding of the aggregation and inference discussion at the public meeting…”
- “HDA urges FDA to begin undertaking the small business assessment mandated by the DSCSA”
- “…various other issues raised during the public meeting…”
The Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) is due to begin on November 27, 2023. That’s the first day that the US pharma supply chain is supposed to fully operate with serial numbers. Yes, serial numbers in human readable and encoded into 2D barcodes will be on every drug packaged after November of this year, but there is only limited use of those serial numbers in the supply chain until 2023. But when the EDDS starts, everything changes. From that point on, every Transaction Information (TI) document must include the full DSCSA Unique Identifiers—including the serial numbers for the first time—that are physically included in the shipment, the Transaction History (TH) no longer needs to be exchanged, and the data exchange requirements change. Let’s focus in on those data exchange changes. Continue reading EDDS: The New Data Exchange Requirements