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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Can GS1 Hold Onto Drug Identification Worldwide?

Some countries mandate the use of GS1 standards for drug product identification and package and case barcodes.  The European Commission seems to tolerate GS1 standards, leaving it up to each member state to decide.  Most use them, a few held onto their own national codes as long as they could.  China is taking their time warming up to the GS1 Global Trade Item Number (GTIN) but it seems to be happening.  That is, I think it’s happening.  The United States has always had its own national numbering system for identifying drugs, known as the National Drug Code (NDC) (see “Anatomy Of The National Drug Code”).  Because they are running out of numbers to identify new manufacturers (labelers), they are considering changes to the NDC that could break the ability to encode an NDC within a GTIN (see “How To Properly Define GTINs For Your NDCs”, “FDA New NDC Format Public Meeting” and “An Open Letter To The FDA: New NDC Format Public Meeting”).  The USA is not the only country to be considering a break with GS1 standards.  Indonesia will allow QR Codes on drug packages, and now there is a movement in the India government to move away from GS1 standards.  What’s going on here?  Can GS1 hold onto drug identification around the world?  Let’s take a look.

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PDSA Releases Prospectus To Prospective Governance Group Members

Last week the Pharmaceutical Distribution Security Alliance (PDSA) released a prospectus for the, as yet, unnamed non-profit organization that they are trying to kickstart to help govern supply chain interoperability of the Drug Supply Chain Security Act (DSCSA) solutions targeting the Enhance Drug Distribution Security (EDDS) phase that will go into effect in November of 2023 (see “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders”).  You can download the prospectus here.

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Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation?

Can President Trump, HHS Secretary Azar and Acting FDA Commissioner Sharpless eliminate/adjust/reinterpret any part of the Drug Supply Chain Security Act (DSCSA) to allow Florida, Colorado, Vermont, Maine or any other US state or territory to import drugs from foreign markets?  Let’s take a closer look at what’s been going on recently with the idea of importing drugs from other markets in an attempt to help American citizens buy them at a lower cost. 

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DSCSA Schedule Assessment, July 2019

It’s time to assess the progress of the industry and the FDA in their quest toward the November 27, 2023 Drug Supply Chain Security Act (DSCSA) goal known as the Enhanced Drug Distribution (EDDS) phase…otherwise known as just ‘2023’ (see “EDDS: The New Data Exchange Requirements”).  Let’s step back and look at where we have come and where we need to go.

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EMVO Calls For Enforcement Of FMD/DR

Wait.  I thought the Falsified Medicines Directive and its companion Delegated Regulation (FMD/DR)—which has been in effect since February 9, 2019—was a mandate that would be enforced.  Turns out, it was apparently just a suggestion.  No actual government enforcement.  In fact, according to new estimates by the European Medicines Verification Organization (EMVO) and the National Medicines Verification Organizations (NMVOs),  only 60% of drug manufacturers and 75% of “other” supply chain actors (pharmacies, hospitals, wholesalers, dispensing doctors etc.) have connected to the medicines verification systems (the “system of repositories” mandated in the FMD/DR).  A partial result is that one out of every 33 verification attempts at pharmacies and hospitals who are connected result in a ‘false alert’.  That is, an alert that the drug being verified is not in the repository or the scan is not being interpreted correctly. 

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China Commits To The Digital Future In Healthcare, Including Pharma Traceability

Tesla Gigafactory 3 near Shanghai, China, June 22, 2019. Screengrab from YouTube video posted by Jason Yang.

I finally had time to finish applying Google Translate to the document issued on May 23, 2019 by the Comprehensive and Planning Finance Department of the China National Drug Administration (CNDA), called “State Drug Administration:  Action Plan to Accelerate the Promotion of Smart Drug Supervision”.  I originally thought “Smart Drug Supervision” was solely related to supply chain supervision, serialization and traceability, but that’s only a part of their plan.

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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.
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