Happy New Year! 2020 is going to be an important year for the industry to work with the FDA to figure out how the 2023 requirements of the Drug Supply Chain Security Act (DSCSA) will be met. A lot has to happen, and so far, the industry is making the right moves to make it happen. The question is, will the FDA join them in time?Continue reading 2020: The View Ahead
The commercial use of barcodes began 45 years ago last week, and RxTrace began 10 years ago this week. These are pretty incredible milestones and it is worth stepping back and thinking about what it all means. GS1 issued a press release about the barcode’s 45th anniversary last week, providing links to several videos. These include some old-timey videos of what grocery checkout was like before barcodes, and when the UPC barcode was first introduced in Troy, Ohio in 1973. It made me feel old.Continue reading Barcodes 45, RxTrace 10
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
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?
The effort to enact a nationwide pharmaceutical serialization law that would preempt all state laws has been going on for four or five years now, and this evening could be the culmination of all of those efforts. The U.S. Senate calendar for today makes the passage of H.R. 3204, the Drug Quality and Security Act a top priority. It finally looks like it is going to happen.
The official Senate calendar for today includes the following as the first order of business:
“ CALENDAR OF BUSINESS
Monday, November 18, 2013
SENATE CONVENES AT 2:00 P.M.
H.R. 3204 (ORDER NO. 236)
An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. Continue reading All Eyes On The U.S. Senate Tonight