The ninth year of RxTrace ends on the Fourth of July, 2018. This year has been marked by a resurgence of activity by the FDA aimed at their obligations under the Drug Supply Chain Security Act (DSCSA). In the last 12 months we have seen the FDA Continue reading RxTrace: Year Nine
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
You 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
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
When I created RxTrace almost six years ago my goal was to introduce and explore new ideas and opinions I had about technology issues related to regulatory compliance within the pharmaceutical supply chain. (see my first essay that explains this purpose: “Welcome to rxTrace”). Hopefully my loyal readers will agree that I have accomplished exactly that, many times. Later, when I struck out on my own as an independent consultant, RxTrace also generated leads which led to new consulting engagements. It served to Continue reading The Future 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?