Tag Archives: VRS

DSCSA

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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GS1 Digital Link

The New GS1 Digital Link Standard

There is competition in the 2D barcode world between Data Matrix, QR Code and PDF417.  Which do you like?  Why?  Before you choose, do you know the features and benefits of each so you can make an intelligent choice?  Now that I’ve asked all those questions, I need to take a step back. For meeting the U.S. Drug Supply Chain Security Act (DSCSA), Congress already made the choice for you.  It’s the same in the E.U., the European Commission made the same choice.  They both picked Data Matrix.  You can’t use QR Code or PDF417 or any other kind of barcode or RFID on prescription drug packages in those markets, or you won’t be compliant and your trading partners won’t want to do business with you.  Does that bother you?  It shouldn’t.  The problem is, some countries around the world are flirting with mandating QR-Codes for drugs rather than Data Matrix. 

Let’s take a look at these three types of barcodes, and in the process, we’ll take a closer look at GS1’s new Digital Link Standard.

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DSCSA, Interoperability

DSCSA: Interoperable Data Exchange In 2023

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Lots of people have been talking lately about what interoperable data exchange in the US pharma supply chain will look like after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023 (see “Does Interoperability Change In 2023?”, “5 Myths About The DSCSA In 2023” and “Interoperability And The DSCSA”). 

Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other.  Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable.  This kind of talk makes me nervous.  Here’s why.

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Verification

GS1’s Messaging Standard For Verification Of Product Identifiers

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For companies in the US pharma supply chain, 2019 is going to be the year of an important milestone of the Drug Supply Chain Security Act (DSCSA).   In November, wholesale distributors will be required to begin issuing verification requests to manufacturers, at the Standardized Numerical Identifier (SNI) level, for any returned drug that is still saleable, before they resell it.  I’ve written a lot about this change in the past.  

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