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
FDA Guidance

FDA DSCSA Deadline Passes Quietly

Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”).  The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”).  But time spent by the FDA to meet their obligations under the DSCSA is “unfunded”.  That is, Congress did not provide any specific additional money to pay for the FDA’s new obligations under the DSCSA.  It is an unfunded mandate.

Fortunately the FDA is Continue reading FDA DSCSA Deadline Passes Quietly →

EU FMD, EUDA

Insufficient Transitional Measures Doom The FMD-EUDA

EU Member States
EU Member States. Source

The pharmaceutical supply chain in most markets is complex, but in my view, the one in the European Union easily takes the prize for being the most complex of any other.  The addition of unit-level serialization and verification of authenticity to that supply chain over the next few years as required by the Falsified Medicines Directive (FMD) and the Delegated Act (EUDA) is going to be difficult (see “Breaking News: The EC Has Published The Delegated Act“).  It represents a huge change to the way drugs are packaged and how they are handled by each entity in the supply chain.  It is vital that the transition Continue reading Insufficient Transitional Measures Doom The FMD-EUDA →

RxTrace

The Future of RxTrace Has Arrived

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RXTRACE_LOGO_Trans_300x113You may recall my essay back in April I called “The Future Of RxTrace”.  Here is an update.  I am still an independent consultant, and I have decided to continue writing RxTrace, no matter what else I end up doing—whether I stay as a consultant, or get a job somewhere.  It has to allow me to continue to publish RxTrace.

But I have also decided that I can no longer Continue reading The Future of RxTrace Has Arrived →

Global Alignment

The Next Markets To Impose Pharma Serialization and Tracing?

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Digital WorldThe pharmaceutical markets that currently have a serialization and/or tracing regulation on the books include the United States, the European Union, China, Brazil, India, Italy, Turkey, South Korea, Argentina, Saudi Arabia and Jordan.  Not all are fully operational yet, but they are official.  This list may be about to grow by two. Continue reading The Next Markets To Impose Pharma Serialization and Tracing? →

DSCSA

Pay No Attention To The Enforcement Delay Unless You Are A Dispenser

iStock_000037865140_smallerAs I reported last Thursday, the FDA published new revised guidance that extends their enforcement delay of the Drug Supply Chain Security Act (DSCSA) data exchange requirements for dispensers by an additional 4 months (see “FDA Extends Dispenser Delay in DSCSA Enforcement“).  What does this mean for drug manufacturers, wholesale distributors and repackagers? Continue reading Pay No Attention To The Enforcement Delay Unless You Are A Dispenser →

DSCSA

FDA Extends Dispenser Delay in DSCSA Enforcement

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FDALogoEarly this morning the FDA published a revised version of its “DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy“, originally published on July 6, 2015 (see “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015“).  That original document established the FDA’s intention to exercise “enforcement discretion” on dispenser transactions that fall under the Drug Supply Chain Security Act (DSCSA) dispenser requirements to receive Transaction Information (TI),Transaction History (TH) and a Transaction Statement (TS) until November 1, 2015, a four month delay in enforcement.

The revision published today pushes Continue reading FDA Extends Dispenser Delay in DSCSA Enforcement →

ANVISA

The Official Suspension of the Three-Lot Pilot in Brazil

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395px-Coat_of_arms_of_Brazil.svgOn October 23, 2015, a very brief resolution was published in the Official Diary of the Union (Diário Oficial da União) (Brazil’s equivalent to the U.S. Federal Register) which formally suspends the 3-lot track and trace pilot that drug registration-holders were formerly required to complete by December 10 of this year (see “Brazil Suspends Pharma Serialization And Tracing Requirements”).  Apparently, that makes it official.  The new resolution is numbered RDC-45 and it is dated October 22, 2015.  Of course, this new resolution is only available officially in Portuguese, but here is an unofficial translation of its core contents in English: Continue reading The Official Suspension of the Three-Lot Pilot in Brazil →

Aggregation, serialization

Aggregation –> Chargeback Accuracy –> ROI

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Last week I attended my favorite annual conference on pharma serialization and tracing in the U.S.:  The Healthcare Distribution Management Association’s (HDMA) Traceability Seminar.  They call it a “seminar” because the subject of the sessions are generally the same every year, but it is better than any other third-party conference, primarily because the right people attend it:  lots of people from drug manufacturers, wholesale distributors and some dispensers.  With this ideal spectrum of attendees, it is very easy to get your questions answered, in the hallway between sessions if not in the sessions themselves.

Of course, every year the folks from the FDA who are directly responsible for writing regulations related to the Drug Supply Chain Security Act (DSCSA) provide Continue reading Aggregation –> Chargeback Accuracy –> ROI →