DQSA: Did The Authors Get The Timeline Right?

2014 enough time graph.zoomIn the last update by the California Legislature, the timeline for the rollout of the California pedigree law was spread out so that it was to take 2 ½ years from the first manufacturer deadline for serialization of 50% of their product until everything was serialized, pedigreed and wholesalers and pharmacies were making use of the serial numbers and pedigrees.  Of course, everyone should be aware by now that the U.S. Drug Quality and Security Act (DQSA) preempted that law and all State and Federal pharma serialization and pedigree laws, and replaced them with new Federal requirements that have a different rollout timeline.

The track and trace provisions of the DQSA are defined within Title II of that act, known as the Drug Supply Chain Security Act (DSCSA).  Some of its provisions begin next January.  Some start in November of 2017 and some start in 2023.  Those are just the big hitting years with other individual requirements starting in the intervening years.

As the California deadlines were looming many people were starting to get uncomfortable.  People worried that there were too many unanswered questions about how to implement some of the pedigree provisions and the hoped for industry consensus over which pedigree standard to use had not materialized (see “California ePedigree Uncertainty”).  There was just too much uncertainty over which investments to make that companies delayed too long, and by then it was too late to be ready in time.  The uncertainty surrounding some of the industry technology decisions that were not being finalized was one of the driving forces behind the coalition that pushed for the DSCSA until it was made a reality.

It is still early in the new paradigm that the new DSCSA requirements produced. But it is not too early to ask, did the authors of the DSCSA get the new timeline about right?

Click the image to enlarge.
Click the image to enlarge.

To the question,

Do you think your company will have enough time to prepare to meet all of the requirements contained within the DSCSA?”,

fully 76% of the respondents to the 2014 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, felt that they will definitely or probably have enough time.  That’s an incredibly high percentage.  Twenty-one percent said they may have enough time and only 3% said they will not have enough time.  In all, that is a very optimistic indicator, but it is still very early in the timeline.  Will that feeling last through the years?  We’ll see.  I’ll ask that same question each year I issue the survey.


2014 Traceability Report Ad.171x258Today I am pleased to announce the availability of the final report of the 2014 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz.  Download a copy right now, free of charge.  Click here, go get it.  You will need to create an account on the site that Frequentz created specially for this report.

The report contains the answers to many of the questions asked on the survey, including:

  • Compared with your company’s efforts to meet the California pedigree law, which describes your company’s likely approach to meeting the Federal Drug Supply Chain Security Act, DSCSA (which is Title II of the Drug Quality and Security Act, DQSA)?
  • Do you think the decision makers within your company understand what will be required of the company to meet the DSCSA?
  • What is your interpretation of the Federal DSCSA regarding “aggregation data” during the first 10 years (phase 1)?
  • Will your company request your suppliers to provide “aggregation data” for some/all shipments?
  • Do you think your company will collect “aggregation data” for your own uses whether or not it is required or your customers demand/request it?
  • In your opinion, will an Electronic Data Interchange (EDI) Advance Shipment Notice (ASN) be used by companies to fulfill the requirement to pass transaction information, transaction history and transaction statements to their customers?
  • Which technology(ies) do you think the industry will eventually settle on after a year or two to fulfill the requirement to pass transaction information, transaction history and transaction statements?

And more.

Download a copy today and see what your peers think.  Let me know what you think of the survey and the report.  Do you think the survey found the true feeling of the industry, or do you think it was flawed in some way?  Do you agree with the answers?  Disagree?  Leave a comment below and share your thinking with everyone.


2 thoughts on “DQSA: Did The Authors Get The Timeline Right?”

  1. Dirk, thanks for pulling this together. Very interesting results. One comment I had did have was your comment on page 16 w/ regards to companies collecting aggregation data. The response to whether or not manufacturers would collect data for their own uses was in my opinion one of the best (no this was not mine):

    “… we recognize the potential benefits, but given the process & equipment costs, plus the technical obsolescence risks, we cannot financially justify the investment…”

    I can’t say I agree with the author’s comments to this response. To make a blanket statement saying that the benefits outweigh the costs in “most” situations is a bit presumptuous isn’t it? Each manufacturer has to evaluate this on a case by case basis. If there are significant costs associated with recalls, diversion, counter-fitting, or charge-backs then there probably is a business case. Each manufacturer is different and each needs to perform their own internal evaluation and put a business case together to justify that the initial spend generate an acceptable yearly benefit; is there a positive NPV?

    Honestly, if there was such business benefit to doing aggregation, why were more manufacturers not doing it before regulators started requiring it 🙂 ?

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