Tag Archives: free

RxTrace

Five Years of Pharma Supply Chain Analysis

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Led_Zeppelin_-_Houses_of_the_HolyLast Friday was the five year anniversary of RxTrace and this is the 255th essay.  I started RxTrace on July 4, 2009 as an outlet for ideas (see my very first essay, “Welcome to rxTrace”).  The results of the last five years have been very rewarding.

Rather than looking back this year, let’s look to the future.  What is coming next?

I always maintain a fairly informal RxTrace list of ideas I want to explore when I get the chance.  With the switch in attention from the California pedigree law to the new Federal Drug Supply Chain Security Act (DSCSA) in the last year, my list grew pretty long and continues to grow.  Here is a list of things I’ve been thinking about and may end up exploring in full RxTrace essays in the coming twelve months: Continue reading Five Years of Pharma Supply Chain Analysis →

PIA, POD, Randomization

DSCSA: Congress Should Have Mandated Randomization

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iStock_000015967853SmallerCongress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain.  Let me explain.

The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA).  The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) (see “Product Identifier Authentication” and “The Aggregation Hoax and PIA”) for at least the first 10 years and possibly beyond. Continue reading DSCSA: Congress Should Have Mandated Randomization →

Suspect Product

The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus

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Suspect Product Draft GuidanceThe FDA published the draft guidance on the identification of suspect product and notification of suspect and illegitimate product on June 11 as mandated by Congress in the Drug Supply Chain Security Act (DSCSA).  The document provides helpful suggestions for those who wish to reduce the risk that they will unknowingly acquire illegitimate product through increased vigilance.  The suggestions are based on the experience the FDA has gained in their investigations over the years of many situations where companies have been duped by criminals into purchasing drugs that turned out to be counterfeit, diverted, stolen, adulterated, or otherwise unfit for consumption.  No legitimate company wants to be a party to buying, selling or dispensing to patients that kind of product, so Continue reading The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus →

Aggregation, PIA

Product Identifier Authentication (PIA)

iStock_000015985566SmallerIn my last essay I touched on the use of Product Identifier Authentication, or PIA, as an alternative to the collection and distribution of aggregation data to allow wholesale distributors and repackagers to meet the verification requirements of the Drug Supply Chain Security Act (DSCSA).  Starting in November of 2018 for repackagers and in November of 2019 for wholesalers, the DSCSA will require these companies to verify that the standardized numerical identifier (SNI)—commonly referred to as “the serial number”—corresponds with one that the manufacturer originally applied to drugs that are found to be suspect, and for any returned drug that will be resold.

As I pointed out in my previous essay (see “The Aggregation Hoax and PIA”), manufacturers and repackagers may be able to choose to pass on aggregation information that would allow wholesale distributors to meet their requirements, or they might choose to offer a PIA service that would allow these companies to check the authenticity of one or more SNIs via a web service. Continue reading Product Identifier Authentication (PIA) →

Aggregation, Product Identifier Authentication

The Aggregation Hoax and PIA

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????????Pharmaceutical manufacturers should be aware that there is a lot of uninformed misinformation going around out there lately about the need for them to supply aggregation data to their trading partners to meet the Drug Supply Chain Security Act (DSCSA) (for more on aggregation, see “Pharma Aggregation: How Companies Are Achieving Perfection Today”, “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”, and “Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…”).  In my view, prior to 2023 you can collect aggregation data if you want to, but don’t let anyone tell you that the DSCSA requires you to.  It doesn’t.  And I also encourage you to be skeptical of any claims that wholesale distributors will not accept your product anytime soon unless you provide them with aggregation data.  Feel free to Continue reading The Aggregation Hoax and PIA →

Cancer, Pelotonia

One Goal: End Cancer.

Newsweek Cancer IssueAbout 30 years ago Newsweek devoted an entire issue to the topic of Cancer.  In the introduction to the issue they made the point that we will never see “a cure for cancer”, because, unlike many other diseases like heart, kidney, liver diseases and diabetes, cancer is actually a family of diseases.  And the family is very diverse.  While some cancers have known cures, others remain challenging.  One important element toward developing a cure for a given type of cancer is to fully understand the conditions and processes that lead to its development, and that takes basic research.  The kind that public and private universities do so well. Continue reading One Goal: End Cancer. →

DSCSA

U.S. Pharma Supply Chain Complexity–Revisited

© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store.
© Copyright 2011 Duncan Champney. used with Permission. This image was created with FractalWorks, a high performance fractal renderer for Macintosh computers. FractalWorks is available on the Mac App Store.

About 3 years ago I published an essay called “U.S. Pharma Supply Chain Complexity” where I attempted to provide a more realistic understanding of the U.S. pharma supply chain than the typical supply chain drawing offers.  That essay was aimed at helping the industry select an approach to meeting U.S. state pedigree laws, which are now preempted by the Drug Supply Chain Security Act (DSCSA).  But, as with many of my older essays, the underlying ideas still have value despite preemption.

In this case, the ideas also provide a clear explanation for why pharma manufacturers should expect to meet the electronic data exchange requirements that are dictated by the large U.S. wholesale distributors, rather than attempting to get them to accept some alternate approach.

So I have copied and pasted that essay below and then edited to serve this new purpose. Continue reading U.S. Pharma Supply Chain Complexity–Revisited →

GS1

GS1 Ratifies Updated Versions of EPCIS and CBV

GS1_logoGS1 just updated their website with the newly updated versions of their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) which were ratified by the GS1 Board on Monday.  Both carry the new version number “1.1”.  The two standards are separate but intertwined because the core business vocabulary is used within the various EPCIS events, so the two standards are likely to always be updated at the same time, as in this case.

This update marks the culmination of several years worth of hard work by the team, co-chaired by Michele Southall of GS1 US and Andrew Kennedy of FoodLogiQ, facilitated by the great Gena Morgan of GS1 US and with Ken Traub serving as the Editor for both standards documents, under the GS1 Global Standards Management Process (GSMP).

WHY THIS IS SIGNIFICANT FOR THE PHARMA SUPPLY CHAIN

This is a significant event for pharma supply chains around the world, but particularly for Continue reading GS1 Ratifies Updated Versions of EPCIS and CBV →