If you are a frequent RxTrace reader, you might have notice that I haven’t been writing for a while. No, I haven’t been sick with Covid-19 (not yet anyway) or sick with anything else. No, I didn’t run for elective office in the recent general election. Any other theories? In reality, I intended to take the month of March off as a well-deserved vacation, and I did that. Then, when Covid-19 hit, there wasn’t much to write about, mainly because of the uncertainty. After that, I got busy with house remodeling projects and consulting. And now I am announcing my retirement from most (maybe not all) consulting, and from RxTrace.
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.
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.
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.
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.
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.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.