Russia: Rationality Makes An Appearance at the 11th Hour. Will It Matter?

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.

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2019 GS1 US Barcode Assessment, Extrapolated

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.

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China Inches Closer To Another Pharma Serialization Mandate

In late August, the China National Medical Products Administration (NMPA) issued three new drug and vaccine traceability guidance documents.  Then in mid-September, they issued five draft documents for comment related to the data exchange protocol for drug traceability.  Based on those publications, it appears that China really is accelerating their move toward traceability of drugs (see “China Commits To The Digital Future In Healthcare, Including Pharma Traceability”).

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Next Week’s HDA Traceability Seminar

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”).

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FDA Inaction On Fixing The NDC Indicates Why They Should Get Out Of The Numbering Business

It’s been eleven months since the FDA held their public hearing to collect ideas for fixing the National Drug Code (NDC) system (see “FDA Seeks Input On The Future Format of the National Drug Code” and “FDA New NDC Format Public Meeting”).  The FDA, themselves, estimated that they may have as little as 10 years before they run out of Labeler Codes, and that was over a year ago.  So now we have less than nine years?  My friends, it’s almost time to panic because the FDA seems to have dropped the ball after hearing from the industry that they would need at least ten years to prepare for any changes that the FDA may make (see “FDA New NDC Format Public Meeting”).

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No Surprise: DSCSA Verification Delay

Dr. Ilisa Bernstein leaves FDA for APhA

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.

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Pharma Counterfeiter Strategies In a Track & Trace World

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.

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Russia Officially Cuts Length of Crypto-code in Half

Earlier this month the Russian Federation finally amended Decree #1556 to cut the length of the Signature portion of the crypto-code element of their pharmaceutical unique identifier in half.  Will that solve the problems the industry uncovered, like the barcode taking up so much space and slow read performance?  Let’s take a closer look at it, but first, a review. 

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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.

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