There are a number of misconceptions floating around the industry right now about what will happen in November of 2023, when the Enhanced Drug Distribution Security (EDDS) phase mandated by the Drug Supply Chain Security Act (DSCSA) begins. It is surprising where you hear some of these, but they are all based on mis-reads of the DSCSA law itself. I’ll explain the myths, and then I will try to provide extracts from the DSCSA that expose them as myths.
MYTH 1: Aggregation will be a regulatory requirement when the EDDS begins
Wrong. The DSCSA does mention the concept of aggregation (and inference) but the only requirements are for the FDA to consider pilots that demonstrate how it might work [see DSCSA Section 582(g)(4)(A)(iii)(I)], if they allow it’s use at all (they will) (see “When Will The DSCSA Ever Require Investments In Aggregation?“). And then the FDA must publish guidance that explains how it might be used appropriately [see DSCSA Section 582(h)(3)(A)]. Even if the FDA decides to allow it, they will certainly not require it’s use. This myth exists because people are confusing a “regulatory requirement” with a “business requirement”. In fact, aggregation data collection will be a “business requirement” because downstream trading partners will demand it (just like the wholesale distributors are currently setting up to demand it to meet their 2019 requirements), and because, for manufacturers to begin including serial numbers in their Transaction Information, as mandated by the DSCSA after the start of the EDDS [see DSCSA Section 582(g)(1)(B)], they will find that aggregation data is the only way to know which numbers to include. That’s still not a regulatory requirement. It is what I call, a “DSCSA-triggered business requirement”. BTW, I am doing a full webinar on the topic of DSCSA-triggered business requirements next week (register here).
MYTH 2: Transaction history goes away when the EDDS begins
I’ll agree, this one is subtle, but still wrong. Technically, Section 582(k)(1) says that the provision and receipt of transaction history will be “sunset” 10 years after the law was enacted. That’s currently the date when the EDDS begins. But the reasons it is a myth that transaction history goes away at that time is that:
- Section 582(g)(1) requires the industry to begin using an “…interoperable, electronic tracing of product at the package level…” at that same time, and,
- subparagraph (E) requires that system to be able to “…promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer…”, which is the very guts of the definition of “Transaction History” as set forth in Section 581(25).
It doesn’t go away, it just has to be constructed by the system whenever it is needed. What is sunset in November of 2023 is the need for the seller to pass a copy of it to the buyer in each sales transaction.
MYTH 3: Each supply chain recipient of drugs during the EDDS must check their transaction history before they can sell or dispense them
No. There are two main times when companies will need to construct a drug’s transaction history, as spelled out in DSCSA Section 582(g)(1)(E). These are:
“(i) in the event of a request by the [FDA] (or other appropriate Federal or State official), on account of a recall or for the purposes of investigating a suspect product or an illegitimate product; or
“(ii) in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the [FDA] (or other appropriate Federal or State official) with a request described in clause (i).”
Of course, if you determine that a drug in your possession or control is suspect, and the supply chain history of the product is part of your suspicion, you should also use the interoperable, electronic tracing system to reconstruct its history as part of your investigation. But the vast majority of drugs passing through the supply chain will not be checked in this way.
MYTH 4: When aggregation errors are found after the EDDS begins, they must be corrected
Wrong. As we saw above, the DSCSA does not mandate the use of aggregation. In fact, it just barely allows the FDA to provide guidance on how it might be used, and only then if the FDA decides to allow it to be used (don’t worry, they will). Aggregation data allows recipients to “infer” the contents of a container of product, like a case and/or pallet. It’s a way of enabling the supply chain to operate as efficiently as possible once the EDDS goes into effect. And that’s why I say the FDA will definitely allow its use. They will be forced to. They have already said that they will not mandate anything that could cause artificial drug shortages (see “Will The DSCSA Cause Drug Shortages After January 1?”). Without widespread use of aggregation and inference during the EDDS, drug shortages would be the norm for all drugs. So the FDA will be forced to allow it.
But what if some aggregation data is constructed incorrectly and the error is discovered somewhere in the supply chain downstream of the manufacturer who provided it? This situation should cause the affected products to become “suspect product”…very briefly. This should trigger an automated suspect product investigation (remember, by this time the entire supply chain is operating under the “…interoperable, electronic [system for] tracing of product at the package level…”). That investigation would start by exercising the manufacturer’s verification service as required in DSCSA Section 582(b)(4) at the fast response time mandated during the EDDS by DSCSA Section 582(g)(1)(C). No more waiting up to 24 hours for the verification response (see “Drug Verification: EU Vs US”).
But we still have to look further, because whenever there are aggregation errors during the EDDS, those errors will almost certainly cause errors in the Transaction Information (TI) (see “DSCSA: Transaction Information”) and that will result in errors in the Transaction History (TH) (see “DSCSA: Transaction History”) that would be constructed from the string of TIs. Remember, in the EDDS, TI must include all of the serial numbers in the transaction. Yes, in the EDDS, these errors in the TIs and the resulting TH will need to be resolved with your supplier, all the way back to the company who generated the erroneous aggregation data.
GS1 US has anticipated the kinds of errors that will occur in the TI and has spent thousands of man-hours constructing guidance on how each one could be resolved during the EDDS. They will publish that guidance very soon and I will write more about it at that time. But the errors in the aggregation data itself will not need to be “corrected” for the following reasons:
- The use of aggregation data and inference will not be mandated (by the FDA anyway), therefore it will be optional. The recipient could have chosen to ignore the aggregation data provided by the seller and open each pallet and case of product and scan the barcodes on each saleable unit. In that situation they wouldn’t even know—nor would they care—that the aggregation data was wrong. Correcting the mandated data (the TIs and resulting TH) will be the focus, not the optional aggregation data;
- Aggregation data is of no use once someone opens the pallet/case and discovers the error. At that time, the reality is now known. The aggregation data can be discarded once the incorrect serial numbers are verified through the manufacturer’s service and once the TI is corrected, if necessary. Once the container is opened, aggregation and inference is over. It is “broken”. You cannot re-seal a case that has been opened and so the aggregation data is no longer valid. The leftover aggregation data is invalid whether it once contained an error or not. In either case, the concept of “correcting it” is not definable. It is meaningless.
Companies will have a hard enough problem correcting their TIs. Being forced to “correct” the aggregation data would be excessive, unnecessary, and, as I said, not even definable.
MYTH 5: The FDA will tell us how the EDDS will work
Wrong. Everything we have seen from the FDA since the DSCSA was enacted in 2013 indicates that they will ask the industry to tell them how the EDDS should work, and as long as it sounds reasonable, they are likely to accept it (see “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?”). That is, they will publish guidance that meets what the industry has proposed. But that requires the industry to come to some kind of consensus about how the EDDS should work in a way that seems to meet the law—at least its intent. That may require new standards and new solutions that do not exist today, particularly the “…interoperable, electronic [system for] tracing of product at the package level”. So here is the sequence that would have to happen between now and November 27, 2023:
- Industry organizes and collects or develops several alternate ideas for the interoperable, electronic system;
- Industry evaluates/debates the alternate ideas and selects the one that is most viable;
- Industry generates a detailed proposal to present to the FDA for their use as the basis for the guidance(s) mandated by the DSCSA;
- FDA publishes the guidances mandated by the DSCSA;
- Industry develops the necessary standards and proposed solution, including any business model that might be necessary (depending on the approach selected);
- Solution providers modify or build new applications that follow the standards for use by individual companies to interact with the interoperable, electronic system;
- Individual companies evaluate, select and deploy the solution from their chosen solution provider (including any necessary internal IT and operational system modifications and retraining);
- Individual companies test their connection and data sharing through the interoperable, electronic system;
- Trading partners begin using their new interoperable, electronic systems for their transactions.
That’s a lot of steps, a lot of cooperation and a lot of coordination. It feels like we are behind schedule already.
I plan to write more about the EDDS in the coming months. Stay tuned.