All posts by Dirk Rodgers

Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners. An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world. Dirk is the author of "The Drug Supply Chain Security Act Explained". View Dirk's LinkedIn Profile Follow Dirk on Twitter

Sponsored: 2020 UDI Conference Is Being Rescheduled

This event is being rescheduled. The dates will be updated when the new dates are known.

Calling all medical device manufacturers, distributors, GPO’s, Providers, and healthcare industry stakeholders to make plans now to be in Baltimore in ???! The 12th annual UDI Conference continues to be the platform for you to stay informed about the latest developments in UDI implementation, enabling technology, regulatory updates, Provider momentum, and Global expansion.

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ACTION REQUIRED: RxTrace Subscriber Update

To tell which type of notification email you are receiving, check the bottom line for the text “Email subscriptions powered by FeedBlitz. If you don’t see it, you are probably receiving the new WordPress notification emails. If you are confused, contact me.

Changes are coming to the way you connect with RxTrace.  Next month RxTrace will return to being free to everyone and open to all.  For the last year, all paid subscriptions have been pro-rated to end in March 2020.  As part of that approaching transition I will switch back to an email notification system that I used between 2010 and 2012.  It’s less configurable and less controllable…but it’s a free service!  What that means is, if you are currently receiving “Feedblitz” email notifications whenever new RxTrace essays are posted—whether on a paid or FREE subscriptionyou will need to “re-subscribe” to the “Wordpress” email notifications to continue receiving notices. Here’s how.

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WHO Publishes Draft Policy Brief for Medicines Traceability Regulations

Late last month the World Health Organization (WHO) published a draft “policy brief” for comments by February 28, 2020.  The draft is aimed at regulators of medicines around the world who might be considering the development of new medicines traceability mandates.  That pool of countries shrinks each year as more and more new mandates are announced, but considering the wide variations in the quality of the existing regulations, guidance aimed at those who would create new mandates is welcome.  Let’s take a look at the draft.

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What Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know?

Friday was “Brexit Day” in the United Kingdom—the last day the UK was a full member of the European Union.  At 11pm London time, the UK entered an 11 month “transition period” that will lead to the full exit on December 31, 2020.  On Wednesday the European Parliament voted overwhelmingly to accept the UK withdrawal agreement, but a lot more negotiations are necessary before a true “deal” is made.

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How The DSCSA Is Designed To Work

There are quite a few people people in the industry who misunderstand how the Drug Supply Chain Security Act (DSCSA) was designed to protect the supply chain. The most common misunderstanding is that it is a full “track and trace” system where drugs are verified at each step. In fact, the DSCSA is mainly just a breadcrumb system that forces companies in the supply chain to retain standardized documentation of supply chain events, “just in case”. Very few drug packages will ever get “verified” at any point in their existence in the supply chain. And that’s by design.

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The HHS Importation Proposed Rule

Last month the US Department of Health and Human Services (HHS) published a new notice of proposed rulemaking (NPRM) related to the importation of finished drugs from foreign supply chains–initially, only Canada but expandable in the future to other countries. The proposal is the result of President Trump’s initiative to lower the price of some medicines and it would invoke Section 804 of the Food, Drug and Cosmetics Act (FD&C)–inserted in the early 2000s–that envisions importation programs, under certain strict conditions. Programs under Section 804 can only be implemented if the Secretary of HHS certifies that the they will pose no additional risk to the public’s health and safety, and will result in a significant reduction in the cost of covered products to the American consumer (see “Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation?” and “Here We Go Again. Florida Flirts With Opening Door To Counterfeits“). Those are high bars. So high, that no Secretary of HHS has been willing to pursue Section 804 Importation Programs (SIPs) until the current one. Will the HHS proposed rule result in programs that pose no increased risk to American consumers? Let’s take a look and see if we can find the answer.

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The Partnership for DSCSA Governance Is Up and Running

Early rejected Logo for the PDG

The most exciting thing happening lately with the Drug Supply Chain Security Act (DSCSA) is the setting up of a new non-profit organization aimed at coordinating the development of “…a comprehensive shared vision for interoperable drug tracing...” so all companies can comply in 2023 and beyond (See “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders“).  The Pharmaceutical Distribution Security Alliance (PDSA) initiated the development of that new organization last year and we now have its name:  The Partnership for DSCSA Governance, Inc., or PDG.  I am told their website will be set up in the next few weeks, so until then, I have posted several of their public documents for RxTrace readers.  Let’s take a look at them.

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