Search Results for: Ken Traub

Barcodes, HDA

The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations

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The Healthcare Distribution Alliance (HDA) (formerly HDMA) published their highly anticipated “Guidelines for Bar Coding in the Pharmaceutical Supply Chain, Quick Start Guide” a few weeks ago.  Do yourself a favor and stop reading this essay right now, click on the link and download your copy and read it.  It is free, and it is essential … Continue reading The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations →

DSCSA

DSCSA: Label Artwork Heartaches

One of the surprising things about industry preparations for the Drug Supply Chain Security Act (DSCSA) is how hard it is to make label changes to add the new DSCSA product identifier barcode (see “The DSCSA Product Identifier On Drug Packages”).  The artwork changes necessary take a lot longer than everyone originally expected.  Companies with hundreds … Continue reading DSCSA: Label Artwork Heartaches →

RxTrace

How RxTrace Became The Target Of A Counterfeiter

The term “counterfeit” is usually defined as an unauthorized copy of a physical thing.  Here is how Dictionary.com defines it: “[koun-ter-fit] … noun 3.  an imitation intended to be passed off fraudulently or deceptively as genuine; forgery.” Counterfeiters seek to expropriate the good reputation, good will and trust in a recognized brand by deceit to … Continue reading How RxTrace Became The Target Of A Counterfeiter →

DSCSA, EUDR

Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution

As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not.  That’s probably what the legislatures and regulators who create the requirements think.  RxTrace readers know it’s not … Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution →

EUDA

The ‘Unique Identifier’ in the EU Delegated Act

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The European Commission published a discussion draft of the European Union Delegated Act (EUDA) about two weeks ago (See “Breaking News: The EC Has Published The Delegated Act“).  The EUDA was called for in the Falsified Medicines Directive (FMD) back in 2011 and is primarily intended to define the “safety features” that must appear on most … Continue reading The ‘Unique Identifier’ in the EU Delegated Act →

DSCSA Product Identifier

DSCSA “Serial Numbers”

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I often write about the fact that drug manufacturers and repackagers that sell into the U.S. market must put “serial numbers”, or “serialize” their drug packages and homogeneous cases before November 27, 2017, but what exactly does that mean? Let’s break it down.  The Drug Supply Chain Security Act (DSCSA) defines the term “Product identifier” … Continue reading DSCSA “Serial Numbers” →

serialization

Pharma Industry Attention Returns to Serialization

Before the passage of the Drug Supply Chain Security Act (DSCSA) on November 27, 2013, the pharma industry was focused pretty well on getting the California-mandated serial numbers on 50% of their drug packages by last Thursday (January 1, 2015), and the remainder of their products by next January.  But that mandate evaporated by federal … Continue reading Pharma Industry Attention Returns to Serialization →