Flag by Zscout370 – Государственный флаг Российской Федерации. Цвета флага: (Blue – Pantone 286 C, Red – Pantone 485 C) взяты из [1][2][3][4], Public Domain, https://en.wikipedia.org/w/index.php?curid=33285605
We’ve seen this sequence of events before in China, Brazil, and India, and now they may be happening in the Russian Federation. The government issues regulatory requirements mandating pharma serialization and tracing with crazy-aggressive deadlines and with confusing, sometimes illogical requirements. Amendments are issued, sometimes helping, sometimes making things worse. Then just before (or just after) the deadline, when confusion reigns, someone else in the government issues calls for rationality, and the government quickly folds their requirements, rethinks and retrenches. In China and Brazil it resulted in a full withdrawal and total redesign of their entire approach…and much more reasonable deadlines. So far in India it has mostly just resulted in pushing the deadline out, again and again, but even there, there are signs that some are proposing a complete withdrawal and redesign. So far in the Russian Federation, all we have is the posting of a set of very rational recommendations by a group of participants in parliamentary hearings of the State Duma Committee on Health Protection. Their hearings were apparently related to the spotty readiness of the government and industry and their report comes less than 3 months from the deadline for serialization and tracing of all drugs.
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.
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.
What is a counterfeiter to do today? Governments around the world are moving
toward standardized serialization and track & trace requirements aimed
directly at their bottom line. It’s
getting harder to fake your way past supply chain workers who are increasingly educated
on what to look for and how to raise their suspicions to the authorities. Or is it?
Let’s take a closer look.
Blockchain technology is also known as “Distributed Ledger” technology. That is, a sequential ledger is shared (distributed) amongst a group of people/entities. This terminology, at least, seems to imply that blockchain would be a good way to represent—in digital form—the transactions in a supply chain, which are distributed geographically and over time. Way back in 2011 I posted an essay aimed at analyzing the viability of three different ways of digitally modeling the pharma supply chain. I called it, “The Viability of Global Track & Trace Models”. I’d like to revisit that essay to see how blockchain technology might affect my conclusions.
India has recently made moves to impose a new barcoding requirement for all drugs procured by state and federal governments for domestic public consumption. The new requirements are part of the preference to “Make In India” program that is intended to “…promote manufacturing and production of goods and services in India with a view to enhancing income and employment.”
The internet lit up last week on the publication of an official warning letter from Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, to John H. Hammergren, CEO of McKesson Corporation, for violations of the Drug Supply Chain Security Act (DSCSA). I’ve written about this situation before, back when the original FDA 483, notice of “inspectional observations”, was originally published (see “McKesson’s DSCSA 483 Explained”), but this new letter provides many more details of the incidents that led to that original notice, including some details of McKesson’s follow-up communications regarding the situation.
Last October the FDA published a draft guidance called “Verification Systems Under the Drug Supply Chain Security Act (DSCSA) for Certain Prescription Drugs” (see “DSCSA: Verification Systems Draft Guidance”). Near the end of the comment period in December, the Healthcare Distribution Alliance (HDA) submitted comments containing proposed changes. Like other comments submitted by the HDA for other FDA DSCSA guidance, these are well worth reading. Once again, the HDA demonstrates their thorough understanding of the DSCSA and their ability to clearly and crisply explain where the FDA’s draft language fails to reflect the language in the original law.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.
