ACTION REQUIRED: RxTrace Subscriber Update

February 17, 2020 Dirk Rodgers

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 subscription—you will need to “re-subscribe” to the “Wordpress” email notifications to continue receiving notices. Here’s how.

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Anti-counterfeiting, Traceability

WHO Publishes Draft Policy Brief for Medicines Traceability Regulations

February 11, 2020 Dirk Rodgers

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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FMD

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

February 3, 2020 Dirk Rodgers

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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DSCSA

How The DSCSA Is Designed To Work

January 27, 2020 Dirk Rodgers 2 Comments

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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Importation

The HHS Importation Proposed Rule

January 20, 2020 Dirk Rodgers

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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PDG

The Partnership for DSCSA Governance Is Up and Running

January 13, 2020 Dirk Rodgers

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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DSCSA

2020: The View Ahead

January 6, 2020 Dirk Rodgers 2 Comments

Happy New Year! 2020 is going to be an important year for the industry to work with the FDA to figure out how the 2023 requirements of the Drug Supply Chain Security Act (DSCSA) will be met. A lot has to happen, and so far, the industry is making the right moves to make it happen. The question is, will the FDA join them in time?

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China

China Sets Aggressive Date for Vaccine Traceability

December 16, 2019 Dirk Rodgers

For a few years now, China has been building a library of documents that define standards for traceability, but no dates have appeared in any of them (see “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”, “China Posts New Draft Pharma Serialization Guidelines”, “China: NMPA Drug Traceability Guidance”, “China Commits To The Digital Future In Healthcare, Including Pharma Traceability” and “China Inches Closer To Another Pharma Serialization Mandate”). In a new posting on their website yesterday, the China National Medical Products Administration (NMPA) provided a notice of aggressive deadlines for vaccine traceability. Let’s take a look at it because a vaccine traceability mandate is probably a herald of a near-term future pharmaceutical traceability mandate.

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…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance