Tag Archives: FDA

Barcodes 45, RxTrace 10

The commercial use of barcodes began 45 years ago last week, and RxTrace began 10 years ago this week.  These are pretty incredible milestones and it is worth stepping back and thinking about what it all means.  GS1 issued a press release about the barcode’s 45th anniversary last week, providing links to several videos.  These include some old-timey videos of what grocery checkout was like before barcodes, and when the UPC barcode was first introduced in Troy, Ohio in 1973.  It made me feel old. 

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Here We Go Again. Florida Flirts With Opening Door To Counterfeits

Earlier this month, the state of Florida (population:  21 million) passed a law that seeks to enable the importation of drugs from Canada (population:  37 million).  The goal is to carve out some way for Florida residents to take advantage of the lower drug prices that Canadian citizens enjoy.  Canada is a “single payer” healthcare country, except for prescription drugs, which are not covered by the Canadian universal public health insurance system.  The reason some drugs are cheaper in Canada than they are here in the US is because the government is allowed to negotiate with drug companies to set pricing for their citizens.  But in the US, Congress has specifically denied that option for itself, except for Medicare.

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Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?

On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors to step up their supply chain security activities another notch.  They are required to:

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Meet The Latest GS1 Key: The Global Model Number (GMN)

GS1 makes modifications and additions to their General Specifications every year—sometimes even twice a year.  The latest is version 19 and was published in January 2019.  The “GenSpecs” contain the full detailed definitions of every GS1 “key” and every GS1 barcode.  While it doesn’t contain the definitions of every GS1 standard, it is the catch-all specification for their traditional core—mostly barcode related—standards.  This is where GS1’s keys are defined, included the Global Trade Item Number (GTIN, Application Identifier, or AI = 01), Global Location Number (GLN), Serial Shipping Container Code (SSCC, AI = 00), Global Returnable Asset Identifier (GRAI, AI = 8003) and all the others.  Last year (GenSpecs version 18) GS1 introduced their latest key, the Global Model Number (GMN, AI = 8013).  It’s an important addition, particularly for healthcare.  Let me explain.

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PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders

Last week the Pharmaceutical Distribution Security Alliance (PDSA) held a workshop for interested stakeholders to brainstorm just how their proposed independent, balanced and sector-neutral organization might meet their vision.  This was the follow-on meeting tied to the publication of two documents last month that provided their “vision” and the actual proposal for the organization (see “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability”). 

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Global Differences In Expiration Date Encoding

Last week the European Medicines Verification Organisation (EMVO) sent a letter to all of their “Onboarding Partners” (OBPs), or drug marketing authorisation holders (MAHs) informing them of a problem EMVO is seeing with many of the expiration dates on drugs being uploaded.  The problem they highlighted in the letter has been recognized by people around the world, and each country has decided to handle it slightly differently.  Drug manufacturers should be aware of these differences to ensure compliance and avoid false failed verifications.  Let’s take a closer look at the issue and what each country expects you to do about it.

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Blockchain And Track & Trace Models

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.

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PDSA’s Proposal for Governance of DSCSA Phase II Interoperability

Independent, balanced, sector-neutral

Last week, the Pharmaceutical Distribution Security Alliance (PDSA) published two papers aimed at kickstarting the creation of a new non-profit organization that would accept the responsibility for setting up and executing governance over Drug Supply Chain Security Act (DSCSA) phase II interoperability (see “A Serious DSCSA Governance Organizational Proposal Emerges From PDSA”).  PDSA defines “DSCSA phase II” to be the same as what the DSCSA text calls the “Enhanced Drug Distribution Security” (EDDS) phase (see “EDDS: The New Data Exchange Requirements”).  The EDDS phase (err, Phase II of the DSCSA) starts on November 27, 2023.  In most informal conversations this phase is usually just referred to as “2023”. 

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