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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GS1 US Publishes New DSCSA VRS Implementation Guide

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.

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DSCSA Uniqueness: SNI vs SGTIN…Again

Ahh, summer.  Some years it seems like everyone is on vacation except me.  I usually only take a few days off here and there in the summer, preferring to do longer vacations in other parts of the year.  So next weekend I’m going to take an extra day off, and so there will be no RxTrace essay published next Monday (the Labor Day holiday here in the US), and I’m going to link to one of my favorite essays from the last year this week as the summer winds down.  This essay was posted on October 7, 2018 under the “A Monthly Slice of RxTrace” on the Center For Supply Chain Studies (C4SCS) website.  Unfortunately I haven’t been able to keep up with the “Monthly” part of that title due to time pressures, but there is some great content out there from the last 12 months (see “A Monthly Slice of RxTrace”).  Other than my diverted attention, nothing has changed so I may post more new content on the C4SCS site in the future if I can make some time.

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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
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the positions of any company, organization or individual other than Dirk Rodgers.

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