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.Continue reading How The DSCSA Is Designed To Work
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?Continue reading 2020: The View Ahead
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).Continue reading DSCSA: Industry Moves Forward
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?Continue reading DSCSA: Will 2020 Be FDA’s Year To Leap Forward?
Last week GS1 US published their “2019 Update: Barcode Readability for DSCSA 2023 Interoperability” in conjunction with the Big 3 wholesale distributors, AmerisourceBergen, McKesson and Cardinal Health. You’ve probably already seen it, but probably not like this. Keep reading.
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.Continue reading 2019 GS1 US Barcode Assessment, Extrapolated
Every year I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar. It’s the one event in the US that is attended by everyone connected with pharma serialization and traceability, including those from manufacturers, 3PLs, repackagers, wholesale distributors, dispensers and solution providers. In that one time and place I can get answers to burning questions about what is going on in the industry and a sense for what people are thinking about a wide range of issues that appear here in RxTrace. The sessions are helpful, but the real goldmine are the hallway conversations. Of course, I’ve written about this before (see “2014 Fall Conference Season Preview” and “Terminology: Track and Trace, and Pedigree”).Continue reading Next Week’s HDA Traceability Seminar
It was fairly easy to predict the FDA would invoke enforcement discretion for the wholesale distributor’s saleable returns requirement of the Drug Supply Chain Security Act (DSCSA), as they announced last Tuesday (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”). The deadline for the mandate was originally this November 27, but with the announcement, will not be enforced until November 27, 2020.Continue reading No Surprise: DSCSA Verification Delay
Last week GS1 US announced that they have published a new implementation guideline to help companies in the US pharma supply chain make use of the new GS1 lightweight messaging standard for verification of product identifiers to meet the saleable returned drug verification requirement of the Drug Supply Chain Security Act (DSCSA). The messaging standard itself was ratified by GS1 in January and it can be used to implement a wide range of product verification schemes in any industry. The new GS1 US guideline is a valuable resource for companies wanting to apply that standard to the problem of verifying drugs that fall under the DSCSA, so it contains a wealth of information needed to ensure interoperability of Verification Router Service (VRS) solutions.Continue reading GS1 US Publishes New DSCSA VRS Implementation Guide