Monthly Archives: October 2010

Digital Signatures

Certifications In A California-Compliant Drug Pedigree

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.I’ve been involved in a number of conversations lately that included differing opinions about what will be necessary to “certify” a drug pedigree in California after their pedigree law goes into effect (2015-2017, depending on your role in the supply chain).  It’s a contentious issue, especially for those who wish that a distributed pedigree model would comply.

The California Law is fairly clear that the pedigree must contain, “A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate.”  And that, among a list of other things, it must include “…the name and address of each person certifying delivery or receipt of the dangerous drug.”

In the California language, a “dangerous drug” is Continue reading Certifications In A California-Compliant Drug Pedigree →

FOB Terms

Pedigree Will Change FOB Terms

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.

fobIn the U.S., the initials FOB stand for “Freight On Board”.  “FOB…” is used here to establish which party, the buyer or seller, pays the shipping costs.  FOB terms are typically either “FOB Shipping Point“, which means the buyer must pay the shipping, or “FOB Destination“, which means the seller must pay the shipping costs.  The “FOB” terms of a given shipment of goods must be agreed to by the buyer and seller, either through a pre-negotiated contract, or through the seller’s acceptance of the terms spelled out in the buyer’s purchase order (PO).

If someone had told me even six months ago I’d be writing an essay about FOB terms I wouldn’t have believed them.  It seems like the most boring topic imaginable.  So what has led me to this boring topic?  Have I finally run out of things to write about? Continue reading Pedigree Will Change FOB Terms →

Partnership For Safe Medicines

Partnership For Safe Medicines Interchange 2010

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Last Friday I attended the first annual Partnership For Safe Medicines (PSM)Interchange 2010 event.  PSM is a coalition of organizations that are committed to the safety of prescription drugs and protecting consumers against unapproved, counterfeit, substandard, mishandled or otherwise unsafe medicines.  PSM was started a few years ago to help educate healthcare professionals and the public about the dangers of counterfeit and other illegitimate drugs.  It is based in Vienna, VA but focuses on the problem globally.  The membership is made up of professional organizations from industry, universities and government.

PSM is led by a distinguished panel of leaders and directors.  The leaders are Continue reading Partnership For Safe Medicines Interchange 2010 →

HDMA

Terminology: Track and Trace, and Pedigree

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I don’t get paid for endorsements.  I don’t sell my opinion.  No one has my thoughts under their control.  So when I tell you that the Healthcare Distribution Management Association’s HDMA Track and Trace Seminar is my favorite pharmaceutical industry serialization and pedigree seminar every year, you should know that’s my honest opinion.  This year, the event will be held on November 8-10 in National Harbor, MD (just south of Washington DC).

BTW, This opinion wasn’t solicited and I am paying full (member) price to attend the event.  This isn’t an advertisement.  It’s what I believe.

It’s an event that is intensely focused on Continue reading Terminology: Track and Trace, and Pedigree →

GS1 Healthcare US

Before You Participate in The GS1 US 2015 Readiness Program, Read This

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.

GS1 US is dedicated to expanding the adoption of GS1 Global’s standards for supply chain interaction in the U.S. market.  Almost every country in the world has a GS1 “Member Organization” (M.O.) that is dedicated to the same thing within their borders.  With the local M.O.’s primary focus on driving adoption, their most valuable tool is that country’s government.  If they can get the government to reference GS1 standards in their laws, their work is much easier.

This isn’t unique to GS1, or course.  All standards organizations know this and they all have various approaches to getting the attention of each country’s government.  There is nothing wrong with this.  In fact, it makes perfect sense since, unlike standards organizations themselves, countries always have very large enforcement wings.

But what happens when those governments are too big to sway easily?  What if it costs too much and takes too long to get them to see the light?  This is when a standards adoption organization needs to get creative.  In my opinion, that’s what has led GS1 Healthcare US to create the “2015 Readiness Program”.  It was out of frustration with the California State Government and with the U.S. Food and Drug Administration (FDA) and their, so far, unwillingness to create laws and regulations that mandate the use of GS1 standards.  Let me explain. Continue reading Before You Participate in The GS1 US 2015 Readiness Program, Read This →