Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…

AggregationDataSurveyResultsZoomOne of the most intense questions about any serialization mandate is whether or not manufacturers would be required to pass “aggregation data” to their customers.  “Aggregation data” is the serial number-based packaging hierarchy of the shipment.  That is, a list of the package-level serial numbers that are contained in each serialized bundle, and then which bundles are contained within which serialized cases and then which cases are contained on which serialized pallet, etc.

You can’t expect to give a couple of workers a handheld barcode reader and expect them to produce six sigma aggregation data.  It is possible to collected highly accurate aggregation data (see “Pharma Aggregation: How Companies Are Achieving Perfection Today”), but it requires systems specifically designed to do so.  The now obsolete California pedigree law did not explicitly require manufacturers to provide aggregation data, but downstream trading partners would have had difficulty complying with the law without it.  Consequently, one of the unwritten goals of industry when negotiating to create the Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act (DQSA), was to defer the need to collect and pass aggregation data as long as possible so that companies would have time to develop and deploy those systems.

In my view, the DSCSA does exactly that.  It delays the mandate for companies to provide aggregation data for at least ten years, until the enhanced drug distribution security system—or phase 2 of the DSCSA—kick in.  However, the big 3 wholesale distributors say they are going to ask their suppliers to provide it anyway, as I documented in the recent essay “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”.  The big-3 seemed to agree that it is not a legal requirement to pass the data, but they just want the data anyway.

There are lots of opinions about what is going to happen regarding aggregation data.  One of the questions asked in the 2014 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, was the interpretation of the DSCSA regarding “aggregation data” during the first 10 years.  Here are the results:

QUESTION 7:  What is your interpretation of the Federal DSCSA regarding “aggregation data” during the first 10 years (phase 1)?

Click image to enlarge.
Click image to enlarge.

 the response was fairly mixed.  However, several themes can be identified:

  • Most agree that the law does not require manufacturers to collect or pass aggregation data during phase 1 (combined 69%).
  • However, included in that percentage are 28% of respondents who believe that manufacturers will discover that they must pass aggregation data along to their customers in order to meet other requirements in the law (this was the top response).  That would mean that supplying aggregation data is an implied requirement in the law.  Perhaps the FDA will eventually make their interpretation explicit so that companies can be confident in their implementation decisions.
  • Only about 1% of the respondents seem to agree with my opinion that the manufacturer’s customers will not even want their aggregation data during phase 1.  We’ll see about that in the next year or so.

This was just one of the many interesting questions asked in the survey.  Download a free copy of the results here.  You will need to create an account on the Frequentz site to get to the download link.

Does your opinion fall within one of these?  If not, leave a comment below with your thoughts on what will happen regarding aggregation data during phase 1 of the DSCSA.


14 thoughts on “Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…”

    1. Thank you for that update Anonymous. If true, it is likely because those in control of the budget got wind of the fact that the law does not require them to do anything with the serial numbers, so there is no requirement to receive aggregation data. As I pointed out in the essay “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?“, manufacturers should collect the data for internal uses even though the law does not yet require them to do so, and even though their customers may not ask for it.


      1. Dirk,
        We agree that though by law we don’t need to pass the aggregation data, but we may end up passing aggregation data for trading partner efficiency. As a manufacturer what is the exact time line that i need to be ready with aggregation data, i mean by when (2017/2019/2013) the big 3 is expecting the manufacturer to pass the aggregation data. Can you answer this?


        1. Naveen,
          I don’t know the answer to your question. If the big 3 wholesale distributors ask manufacturers to provide aggregation data, only they know what that date is. Check with them.

  1. Dirk,
    As always, those who seek minimal, just-in-time compliance will pay more in the long term. This will occur directly because “bolt-on-later” is usually trickier than “built-in-now”. They might also be simply out-competed by their more imaginative and far-sighted peers with early adoption of future-ready data management and supple supply chains.
    Compliance is a given, of course, but rather than ask only what they MUST do, a better way is for companies to consider their commercial evolution over the same time frame as DQSA. They should ask themselves what they NEED to do, from first principles, to build a winning organisation. I suspect in most cases the answer includes aggregation.
    Best, Mark

    1. The same statement could have been said about RFID in 2008. How did that turn out? Until the phrase “supply chain efficiencies” adds dollar value to manufacturers or is required, saying such a phrase has no substance to justifying aggregation.

  2. Dirk, the law clearly does not require aggregation; although as you mentioned in the CA Law it is implied in phase 2 (2023 timeframe). The Big 3 wholsalers likely would not want aggregated data for a number of reasons. First, they may then be required to pass aggregated data downstream. Wholesalers and HDMA fought to not be required to pass lot information to their downstream customers and the DQSA exempts them from doing so in phase 1; so it is doubtful they would consider passing serialized data. Serialized data would be a benefit to wholesalers to identify that returns were actually for product they sold which is why they may want it. However it would have little to do with patient safety if it was not passed downstream. Aggregated unique item identification is desirable by manufacturers as it is a deterrent for diversion and counterfeit detection. Currently a manufacturer knows the lot number shipped to a wholesaler, but the same lot number is shipped to multiple wholesalers. When illegitimate/suspect product is found in the supply chain, a manufacturer cannot currently identify the immediate downstream customer to begin an investigation. If patient safety is the goal of the law, aggregation and then verification by dispensers has to be the end game. The ball was moved downfield with the DQSA, but we are not even in the red zone until interoperability across all supply chain partners is required.

  3. I believe we were the first companies to have a validated serialized packaging line in operation and a couple of years ago passed aggregation data to one of the “big 3” companies who wanted it to test their systems to accept it and it was a success.

    Speaking with our serialization vendor they tell us other companies who already began installing serialization equipment on their packaging lines are going to continue to do so and not stop due to the DQSA superseding the California State law.

    So with that said it seems the “big 3” will gladly accept aggregation data. My conclusion is companies already spent millions of dollars to invest in serialization of their products and will move forward to pass aggregation data downstream. Why wouldn’t they?

    1. Thanks Mike,
      You may very well be right. Companies have made some big investments for compliance with the California law. But that law is obsolete and everyone should be reevaluating all of their investments and existing systems in light of the new DSCSA that is part of the DQSA. One possible answer to your question, “Why wouldn’t they?” is that drug wholesale distributors may not want to deal with mountains of data that they are not legally obligated to deal with. Aggregation data is, fundamentally, serialization data. Unlike the California law, the new law does not require wholesalers to do much of anything with serial numbers until 2023. We may find that the people who pay the bills in those companies might not want to pay bills that are not absolutely necessary to meet current regulatory requirements–no matter what the IT folks in those organizations want to do.

      We’ll just have to see what happens going forward after everyone solidifies their plans to address the requirements of the new law.

      Thanks for reading and commenting.


  4. Love the passion and interesting perspectives. I somewhat disagree that efforts to detect the counterfeit before it gets to the dispenser is the best way to protect patients. My belief has been and remains that pedigrees and passing serialized information at change of ownership is a moderately effective tool to catch the bad guys; whether they be counterfeiters, diverters or bad actors in the supply chain. However it is not as effective for protecting patients until dispensers authenticate the serial number prior to a patient receiving the product. The European model or, end point verification, although born of reimbursement fraud is the better option for patient safety. The bottom line is that a manufacturer’s aggregation is only good to the next link in the supply chain. Actually aggregation on a packaging line breaks down as soon as a warehouse order calls for less than a pallet, case or bundle and reaggregation is required. Wholesalers most often break down the aggregated pallets, cases and bundles before shipping to a retailer or other wholesaler and need to create a new aggregation for that shipment. Retailers need to break down aggregated totes that they receive. The bottom line is that an individual serialized unit likely goes through multiple aggregation and reaggregation processes before getting to a patient. Each of these activities is an opportunity for error and illegitimate product entering the supply chain. Returns is a whole other scenario ripe for entry. When it comes to patient safety, authenticating that the serial number on the saleable unit is the serial number assigned by the manufacturer is the optimal safety measure until we can have patients authenticate; which by the way is done in lesser developed countries with greater incidents of counterfeits. I am all for catching the bad guys so I am not arguing against perigrees and aggregation/inference practices. But I am more concerned with doing everything we can to ensure the patient gets the legitimate product. Unfortunately the law puts this out to 2023 at the earliest. And unfortunately pharmacy has and continues to lobby against having to authenticate serial numbers….one more scan prior to dispensing. So yes manufacturers can aggregate and wholesalers can infer the contents of a pallet, case and bundle at the point of receipt, but if aggregation/pedigree is to be effective each hop downstream needs to be part of the process to reaggregate their shipments. I doubt this will happen until the law requires it. I have personally heard the representatives of supply chain partners and industry organizations oppose the passing of serialized information and authentication. Regarding tracking a package, it is easy to track a package like a shipment of flowers; it’s the individual flower within the bouquet that is the challenge.

  5. I’m all for authentication of the saleable unit at point of sale. Manufacturers will need to generate aggregation data during manufacturing (to facilitate product recalls and catching the counterfeiters), but sharing that data could raise potential data security issues. Maybe the manufacturers should exclusively retain aggregation data. Supply chain partners can scan pallet,shipper and unit codes as ‘incoming from’ or ‘outgoing to’. These scan events would be logged in the manufacturer’s secure dsata system without visibility of aggregation data being shared with the supply chain partner. That way,track and trace could be implemented with less cost and hassle to supply chain partners,and with reduced opportunity for counterfeiters to obtain serialisation data.

  6. In the United States those who work on and represent pharmacy and wholesale distribution don’t consider patient needs above theirs. Their lobby efforts are shameful and harmful to the community. Point of dispense authentication should be mandatory.

  7. Some interesting perspectives and concepts with many similarities to those encountered in the electronics industry. Implementing the traceability/authenication in the consumer electronics supply chain faces its greatest roadblock at the retail outlet, because of the lack of mandate. High volumes, “partialling” boxes and/or pallets (aggregation & de-aggregation), customer returns, etc. can be handled efficiently and cost effectively. But driving the changeover from 1D to 2D barcode readers gets significant pushback because of cost to the retailers. Regardless of this “hole” at the very end of the chain, the paybacks, internal to the manufacturer makes item/unit level traceability/authentication money well spent.
    To establish full pharma supply chain traceability/authentication, I’d put my money on legal mandate.

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