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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Russia: CRPT Posts Test Methodology For Crypto Code

CRPT, the company authorized to conduct the development, piloting and operation of the Russian government pharmaceutical serialization and tracing system, posted an important document last week.  The document is intended “…to unify the process of testing printing on the packaging of medicinal products of identification features using the verification code and electronic signature with the content in it of a different number of characters and the aggregation process of drug manufacturers to obtain comparable test results and their applicability in the framework of industrial implementation.”  Will it help you? 

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DSCSA: What Wholesalers Want

Last November pharma manufacturers selling into the U.S. market had to meet a big serialization and verification deadline under the Drug Supply Chain Security Act (DSCSA).  Now, pharma wholesale distributors in the United States are facing their own important deadline this coming November.  Remember how manufacturers had to scramble and go through a lot of pain to achieve compliance in time?  Your friendly neighborhood wholesale distributors—big and small—are going through that now.  And the problem is…they can’t do what they need on their own.  They need all drug manufacturers to do something so that they can be compliant with the DSCSA in November.

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DSCSA: Interoperable Data Exchange In 2023

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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Barcoding Regulation For India’s Domestic Drug Supply

India has recently made moves to impose a new barcoding requirement for all drugs procured by state and federal governments for domestic public consumption.  The new requirements are part of the preference to “Make In India” program that is intended to “…promote manufacturing and production of goods and services in India with a view to enhancing income and employment.”

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FDA Hammer Comes Down On McKesson For DSCSA Violations

The internet lit up last week on the publication of an official warning letter from Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, to John H. Hammergren, CEO of McKesson Corporation, for violations of the Drug Supply Chain Security Act (DSCSA).  I’ve written about this situation before, back when the original FDA 483, notice of “inspectional observations”, was originally published (see “McKesson’s DSCSA 483 Explained”), but this new letter provides many more details of the incidents that led to that original notice, including some details of McKesson’s follow-up communications regarding the situation. 

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HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems

Last October the FDA published a draft guidance called “Verification Systems Under the Drug Supply Chain Security Act (DSCSA) for Certain Prescription Drugs” (see “DSCSA: Verification Systems Draft Guidance”).  Near the end of the comment period in December, the Healthcare Distribution Alliance (HDA) submitted comments containing proposed changes.  Like other comments submitted by the HDA for other FDA DSCSA guidance, these are well worth reading.  Once again, the HDA demonstrates their thorough understanding of the DSCSA and their ability to clearly and crisply explain where the FDA’s draft language fails to reflect the language in the original law. 

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FDA Announces Start Of DSCSA Voluntary Piloting Program

Starting tomorrow companies in the US supply chain wishing to volunteer to participate in FDA-sanctioned Drug Supply Chain Security Act (DSCSA) pilots will have just 30 days to apply.  Applicants are asked to propose pilots aimed at the goals of the FDA program.  These include:

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