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
Our industry is international by nature. Protecting patients from counterfeit drugs is partly a humanitarian mission and partly a business. Consequently, I don’t worry much about who is looking for information on RxTrace. I have happily fielded queries from Russia, China and even Iran, countries who are not always political “friends” of my beloved country.
But what if a counterfeiter is seeking information Continue reading My Handshake With Germany
I started writing RxTrace seven years ago on July 4, 2009 (see “Welcome to rxTrace”). Not much has changed in my goals since then. My interests still revolve around the intersection between the healthcare supply chains, track and trace technology, standards and global regulatory compliance. I still like exploring ideas, including those that might not be mainstream yet. My only regret is Continue reading Seven
The term “counterfeit” is usually defined as an unauthorized copy of a physical thing. Here is how Dictionary.com defines it:
3. an imitation intended to be passed off fraudulently or deceptively as genuine; forgery.”
Counterfeiters seek to expropriate the good reputation, good will and trust in a recognized brand by deceit to carve out undeserved profit or other gain. Their goal is to Continue reading How RxTrace Became The Target Of A Counterfeiter
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