All posts by Dirk Rodgers

Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners. An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world. Dirk is the author of "The Drug Supply Chain Security Act Explained". View Dirk's LinkedIn Profile Follow Dirk on Twitter

Japan Moves To Mandate Barcodes For Drug Traceability

Last week, the Japan Diet, the bicameral legislature, enacted a bill that amends the Pharmaceuticals and Medical Devices (PMD) Law there. From the limited information I have seen from GS1 Healthcare and from online articles I found through Google, it appears that one of the many things the new bill does is add a new barcoding mandate.  Previously, barcoding of medicines and medical devices in Japan was only recommended.

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DSCSA: Industry Moves Forward

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).

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Brazil Moves to Formalize A Phased Rollout, Starting Next October

If you do business in Brazil then you know that everything is published there in Portuguese, including ANVISA’s documents.  It is necessary to translate everything unless you can read Portuguese.  I can’t, so whenever something comes out I have to do a quick translation to get an idea of how significant it is.  Last week, ANVISA published two new documents related to their future pharma serialization and traceability mandate.  They are important, because they relate directly to the schedule and some of the requirements of Brazil’s pharma serialization and traceability mandate.

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DSCSA: Will 2020 Be FDA’s Year To Leap 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?

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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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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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