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
I really enjoy this time of year because business demands usually slow down enough to allow for me to catch up on some things I have neglected, review the year and do some planning for the coming year. I always take time to backup my computers and clean out my email. I do a lot of introspective thinking during the last two weeks of the year, and I normally like to do some writing that is way outside my normal fare. This year I may not have time for some of that because we plan to spend a lot of time with our family. I hope you are able to do that too.
Next year looks like it is going to be very busy for those who follow RxTrace because Continue reading Rest Up, 2014 Will Be Very Busy
Last month I published an essay that analyzed the exemption language related to combination products contained in the old California pedigree law and in H.R. 3204, which was later signed into law as the Drug Quality and Security Act (DQSA) (see “Drug-Device Combo Products Under State And Federal Pedigree Laws”). In that essay I showed how these exemptions were very similar because both were based on the existing definition of a “combination product” from 21 CFR 3.2(e). My assessment of the effect of the wording in the old California pedigree law is still valid, in my opinion, but I now believe my analysis of the language in H.R. 3204 was incorrect. Here is why. Continue reading Correction: Your Drug or Biologic Combination Product Is Probably NOT Exempt From The DQSA
During last week’s FDA DQSA supply chain stakeholder’s conference call I was heartened by Ilisa Bernstein’s comments about the linear barcode rule (she says the FDA just calls it “the barcode rule”). The question was asked by a caller whether or not the linear barcode requirement might be dropped in light of the 2D barcode requirement contained in the Drug Quality and Security Act (DQSA) since some drug packages are too small to accommodate both barcodes. This is an excellent question and I was happy the caller asked it so directly.
In her response, Dr. Bernstein pointed out that Continue reading Will The FDA Eliminate The Linear Barcode On Drugs?
Tuesday’s FDA stakeholder call with Dr. Ilisa Bernstein, deputy director in the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance, was helpful if only to let us know that the FDA has begun to mobilize immediately after the Drug Quality and Security Act (DQSA) was signed into law by President Obama last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law” and “InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13”). The call was very thin on what their plan is, but that was the point. Dr. Bernstein wanted everyone to know Continue reading FDA: Ready, Set, Hike!
With the enactment of the Drug Supply Chain Security Act of 2013 (DSCSA) last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“) I have decided to conduct an annual survey of U.S. pharma traceability preparedness. You can fill out the survey by clicking on this link: Take the 2014 RxTrace U.S. Pharma Traceability Survey Now.
The answers you provide anonymously will be aggregated to provide a view of the thinking of the industry, solution providers, regulators, academics and more, in addition to a view of the preparedness of the industry to meet the new federal pharmaceutical traceability law. Please make sure your company is represented in the data that is collected. The survey is Continue reading Announcing The 2014 RxTrace U.S. Pharma Traceability Survey
On November 27, 2013 President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“). That act has many provisions, but one is to preempt all existing and future state pharmaceutical serialization and pedigree laws like those that previously existed in California and Florida. Because of the preemption language contained within the DQSA, the information contained within many previous RxTrace essays is now obsolete. Some essays are entirely obsolete and some are only partially obsolete. This is because many of these essays contain ideas and discussion about topics that will also apply to the new federal law in almost the same way that they applied to the California and/or other state laws that are now inoperative. In those cases, the ideas and discussion are not obsolete, only their application to the state law(s) is now obsolete.
To address this issue I have Continue reading Preemption: What Does It Mean?