Drug manufacturers facing the November 27, 2017 deadline for applying unique identifiers to their products should take care when interpreting the FDA’s recent draft compliance policy. All the headlines scream (including last week’s RxTrace essay: “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) that the Drug Supply Chain Security Act (DSCSA) serialization deadline is delayed, but there are important nuances to the delay. Don’t just read the headlines, read the whole articles. Officially, the deadline remains the same. Yes, the FDA will look the other way for some drugs, but for others, the deadline still appears to apply. How do you know if your drugs are those where the deadline still applies? Read on. Continue reading DSCSA and RxTrace: The Song Remains The Same
This is the sixth anniversary of the beginning of RxTrace and over that time I have published 325 essays. Pageviews and subscribers to RxTrace have continued to rise the entire time. I thank you all for that because I enjoy writing (and thinking), and without you as readers, I would not be able to do it.
Many people have asked what led me to start RxTrace in the first place? In fact, there were three people who contributed to that decision. Continue reading Six Years of RxTrace
Even before the Drug Quality and Security Act (DQSA) was passed last November I began to study Title II, the Drug Supply Chain Security Act (DSCSA). But as soon as it was passed, I began to devote all of my spare time to that study. The DSCSA text is much more complicated than any previous U.S. drug pedigree law and so, to really understand it, I’ve read it through many times, concentrating on different parts at different times. I wanted to understand the law as well as I had come to understand the California pedigree law, the one that previously was the most complex.
It has taken this long, but I can now say that I have cracked it. Continue reading The Drug Supply Chain Security Act Explained
One of the most intense questions about any serialization mandate is whether or not manufacturers would be required to pass “aggregation data” to their customers. “Aggregation data” is the serial number-based packaging hierarchy of the shipment. That is, a list of the package-level serial numbers that are contained in each serialized bundle, and then which bundles are contained within which serialized cases and then which cases are contained on which serialized pallet, etc.
You can’t expect to give a couple of workers a handheld barcode reader and expect them to produce six sigma aggregation data. It is possible to collected highly accurate aggregation data (see “Pharma Aggregation: How Companies Are Achieving Perfection Today”), but it requires systems specifically designed to do so. The now obsolete California pedigree law did not Continue reading Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…
In the last update by the California Legislature, the timeline for the rollout of the California pedigree law was spread out so that it was to take 2 ½ years from the first manufacturer deadline for serialization of 50% of their product until everything was serialized, pedigreed and wholesalers and pharmacies were making use of the serial numbers and pedigrees. Of course, everyone should be aware by now that the U.S. Drug Quality and Security Act (DQSA) preempted that law and all State and Federal pharma serialization and pedigree laws, and replaced them with new Federal requirements that have a different rollout timeline.
The track and trace provisions of the DQSA are defined within Title II of that act, known as the Drug Supply Chain Security Act (DSCSA). Some of its provisions begin next January. Some start in November of 2017 and some start in 2023. Continue reading DQSA: Did The Authors Get The Timeline Right?
One of my four brothers has a journalism degree with a photojournalism emphasis from Northern Illinois University. Randy started his career at the Kewanee Star Courier (Illinois) as a photographer back in the 1980’s, before the internet became a place where many people looked for their daily news. His next career move was to become the editor of our home-town weekly newspaper, the Galva News (Illinois)—still before the internet news boom. I lived in Wisconsin at the time but I subscribed to the Galva News so I could read his essays. He produced a regular weekly column where he often wrote comical essays about what it was like to grow up in our family with five little boys, one big boy (our dad) and one regular adult (our mom). Lots of really great writing.
But, working for small-town newspapers, Randy did not just take photographs for publication, he also wrote news articles for both newspapers. That is, he was not just a photojournalist, he was a full journalist.
I, on the other hand, was trained as an engineer. I have never really thought the term “web log” described the contents of RxTrace very well but Continue reading This Is Not Journalism
The February issue of Healthcare Packaging Magazine is out today in digital form and it contains my first contribution as Contributing Editor in my regular column called…wait for it…RxTrace! Check it out here and let me know what you think. Subscribers of the print magazine should receive their copy in the mail soon. This will expose my ideas to an even wider audience and to more traditional readers.
I’d like to thank the great folks at Summit Media Group for extending the invitation and working it out. Particular thanks go to Editor-In-Chief Jim Butschli and Publisher Jim Chrzan. Great work guys. It looks fabulous. Continue reading New RxTrace Column in Healthcare Packaging Magazine
Today I am republishing one of my long lost classic essays, “Who Will Decide Which Pedigree Model You Will Invest In?“. This essay was first published on November 15, 2010 but was removed from public view in December of that year. Next week I will republish the second long lost essay, “Standards and Guidance For U.S. Pharma Supply Chain Technology“, originally published on November 22, 2010. Both of these essay contain my thoughts on how the industry will eventually resolve the current confusion over which approach to ePedigree everyone in the U.S. supply chain should take. Check them out and see if Continue reading Return Of Two Classics