Search Results for: RFID

Barcodes

Why NOW Is The Time To Move Away From Linear Barcodes

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Linear barcodes have served us well for almost half a century, but NOW is the time to move on to something else in the global pharmaceutical supply chain.  I think most people already agree with that but I’m not sure everyone fully appreciates exactly why that is.  It’s important to fully understand the reason why … Continue reading Why NOW Is The Time To Move Away From Linear Barcodes →

Repackaging

Repackaging Drugs Under A Serialization Regulation

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The California ePedigree law goes into effect for manufacturers in 2015/2016.  In mid-2016 distributors and repackagers will need to comply.  The California pedigree law includes the need for manufacturers and repackagers to serialize drugs at the smallest level of distribution to pharmacies.  That’s just one of the requirements, they also need to make reference to … Continue reading Repackaging Drugs Under A Serialization Regulation →

SNI

Anatomy Of An FDA SNI

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The U.S. Food and Drug Administration (FDA) published their “Standardized Numerical Identification (SNI) for Prescription Drug Packages – Final Guidance” document almost two years ago (see my essay “FDA Aligns with GS1 SGTIN For SNDC” from back then).  The guidance was published as purely non-binding recommendations that reflected the Agency’s current thinking, but in my … Continue reading Anatomy Of An FDA SNI →

standards

Anatomy of a GTIN

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2012 is the year of the GTIN in the U.S. healthcare supply chains as christened by the largest hospital group purchasing organizations (GPOs) in their so-called “Sunrise 2012” program.  They have asked all of their suppliers to switch from proprietary product codes to GS1’s Global Trade Item Number (GTIN) standard in catalogs, B2B communications and … Continue reading Anatomy of a GTIN →

HDMA

Updated HDMA Bar Code Guidance: A Must Read

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In a long awaited and much anticipated move the Healthcare Distribution Management Association (HDMA) published updated guidance for the formatting, encoding and placement of barcodes in the U.S. pharmaceutical supply chain.  The document is called “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain 2011”.  The guidance is aimed mostly at pharma manufacturers and … Continue reading Updated HDMA Bar Code Guidance: A Must Read →

pedigree laws

Should Regulations Dictate Technology?

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In the U.S. pharmaceutical supply chain this question becomes, should regulators—state legislatures, state Boards of Pharmacies, Congress or the FDA—mandate specific technology for serialization, ePedigree and other regulations?  This question arises whenever a new regulation is considered by any of these bodies or agencies.  It’s an important question now that the FDA is considering standards … Continue reading Should Regulations Dictate Technology? →

California Pedigree

Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1

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For the application of unique serial numbers, or Standard Numerical Identifiers (SNIs), to packages as part of compliance with the California Pedigree Law in 2015-2017 , GS1’s Electronic Product Code (EPC), particularly in barcode form, is the clear winning standard.  But there seems to be a very common misconception going around that for pedigree data management, all you need to … Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1 →

Anti-counterfeiting

Pharmaceutical Anti-Counterfeiting, A First-Rate New Resource

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Earlier this summer J. Wiley & Sons published a new book called “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs” by Mark Davison, CEO of Blue Sphere Health, a pharmaceutical consultancy.  I pre-ordered it on Amazon.com in the spring and it was finally delivered in July.  You may have noticed the image and link I … Continue reading Pharmaceutical Anti-Counterfeiting, A First-Rate New Resource →