As 2020 transitioned to 2021, we took another step closer toward the implementation of 2023 Drug Supply Chain Security Act, Phase II. From manufacturers to wholesalers, pharmacies and other stakeholders, many uncertainties are swirling around the subject, so today we are writing to try to dispel some of the concern.
Let’s start with an overview of DSCSA Phase II and its components.
DSCSA Phase II, which goes into effect on November 27, 2023, is intended to roll out the electronic tracing of products at the package level. To make this happen, the 2023 requirements are comprised of three specific parts, and they are as follows:
On March 10, 2020, Alex M. Azar II, Secretary of Health and Human Services of the US government, declared a public health emergency (PHE) under Section 319F of the Public Health Service Act “…to provide liability immunity for activities related to medical countermeasures against COVID-19.” This action immediately opened an exemption embedded in the Drug Supply Chain Security Act (DSCSA) for the “covered persons” performing the “covered countermeasures” aimed at the specific “threat” in the covered “geographic area”, for the identified “population” for the “effective time period” specifically identified in the declaration.
There are quite a few people people in the industry who misunderstand how the Drug Supply Chain Security Act (DSCSA) was designed to protect the supply chain. The most common misunderstanding is that it is a full “track and trace” system where drugs are verified at each step. In fact, the DSCSA is mainly just a breadcrumb system that forces companies in the supply chain to retain standardized documentation of supply chain events, “just in case”. Very few drug packages will ever get “verified” at any point in their existence in the supply chain. And that’s by design.
Happy New Year! 2020 is going to be an important year for the industry to work with the FDA to figure out how the 2023 requirements of the Drug Supply Chain Security Act (DSCSA) will be met. A lot has to happen, and so far, the industry is making the right moves to make it happen. The question is, will the FDA join them in time?
Some members of the US pharmaceutical supply chain are not waiting for the FDA to make the next move (see “DSCSA: Will 2020 Be FDA’s Year To Leap Forward?”). Instead, they are proactively organizing and setting the standards that will most likely be used to meet the requirements of the Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA), which goes into effect on November 27, 2023. Forward motion has been made over the last month on two fronts: The DSCSA governance organization and the Verification Router Service (VRS).
When it comes to the Drug Supply Chain Security Act (DSCSA), the FDA seems to alternate between hibernating, and leaping forward. 2017 through mid-2018 was a leap forward period with the publication of 8 draft or final guidance documents and 3 public meetings. Then in 2019, hibernation. Yes, FDA’s list of DSCSA guidance and policy documents has two entries for 2019 so far, but one is simply a notice reopening the comment period on the DSCSA Pilots request for information that was originally opened in 2016 and 2017. The other is the compliance policy that provides one year of enforcement discretion for the 2019 wholesaler saleable returns requirement (see “No Surprise: DSCSA Verification Delay”). Neither were very taxing on the FDA to prepare. What should the FDA do next? What should they be doing right now?
This year there was a significant jump in the percentage of drug products containing the 2D barcode mandated by the Drug Supply Chain Security Act (DSCSA). The problem is, for the last three years they have published their data four to five months after they collected the data (see also “Wholesalers Find Troubling Results In DSCSA Barcode Assessment“). What everyone really wants to know is, what percentage of drugs would have been marked with the 2D barcode in November of 2018 and today, not back in June of those years. And with three years’ worth of data, you can make a reasonable extrapolation of the data for the November dates, if you just apply a little spreadsheet and graphics skills. Let’s try it.
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