Last week the FDA posted new guidance called “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency” that directly addresses everything I talked about in my last essay, “DSCSA Exemption For Public Health Emergencies” and more. This new guidance was “fast-tracked” and went direct to “final” status, skipping the “draft” stage used for most guidances. The FDA determined that the “…prior public participation for this guidance is not feasible or appropriate.” Things are moving fast at the FDA regarding Covid-19 so if you’re reading this essay more than a week or two after it is published, I suggest you search the FDA website to confirm that its contents are still fully valid. Make sure you check the links below for more info.Continue reading FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE
Changes are coming to the way you connect with RxTrace. Next month RxTrace will return to being free to everyone and open to all. For the last year, all paid subscriptions have been pro-rated to end in March 2020. As part of that approaching transition I will switch back to an email notification system that I used between 2010 and 2012. It’s less configurable and less controllable…but it’s a free service! What that means is, if you are currently receiving “Feedblitz” email notifications whenever new RxTrace essays are posted—whether on a paid or FREE subscription—you will need to “re-subscribe” to the “Wordpress” email notifications to continue receiving notices. Here’s how.Continue reading ACTION REQUIRED: RxTrace Subscriber Update
Friday was “Brexit Day” in the United Kingdom—the last day the UK was a full member of the European Union. At 11pm London time, the UK entered an 11 month “transition period” that will lead to the full exit on December 31, 2020. On Wednesday the European Parliament voted overwhelmingly to accept the UK withdrawal agreement, but a lot more negotiations are necessary before a true “deal” is made.Continue reading What Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know?
The most exciting thing happening lately with the Drug Supply Chain Security Act (DSCSA) is the setting up of a new non-profit organization aimed at coordinating the development of “…a comprehensive shared vision for interoperable drug tracing...” so all companies can comply in 2023 and beyond (See “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders“). The Pharmaceutical Distribution Security Alliance (PDSA) initiated the development of that new organization last year and we now have its name: The Partnership for DSCSA Governance, Inc., or PDG. I am told their website will be set up in the next few weeks, so until then, I have posted several of their public documents for RxTrace readers. Let’s take a look at them.Continue reading The Partnership for DSCSA Governance Is Up and Running
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
Some members of the US pharmaceutical supply chain are not waiting for the FDA to make the next move (see “DSCSA: Will 2020 Be FDA’s Year To Leap Forward?”). Instead, they are proactively organizing and setting the standards that will most likely be used to meet the requirements of the Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA), which goes into effect on November 27, 2023. Forward motion has been made over the last month on two fronts: The DSCSA governance organization and the Verification Router Service (VRS).Continue reading DSCSA: Industry Moves Forward
We’ve seen this sequence of events before in China, Brazil, and India, and now they may be happening in the Russian Federation. The government issues regulatory requirements mandating pharma serialization and tracing with crazy-aggressive deadlines and with confusing, sometimes illogical requirements. Amendments are issued, sometimes helping, sometimes making things worse. Then just before (or just after) the deadline, when confusion reigns, someone else in the government issues calls for rationality, and the government quickly folds their requirements, rethinks and retrenches. In China and Brazil it resulted in a full withdrawal and total redesign of their entire approach…and much more reasonable deadlines. So far in India it has mostly just resulted in pushing the deadline out, again and again, but even there, there are signs that some are proposing a complete withdrawal and redesign. So far in the Russian Federation, all we have is the posting of a set of very rational recommendations by a group of participants in parliamentary hearings of the State Duma Committee on Health Protection. Their hearings were apparently related to the spotty readiness of the government and industry and their report comes less than 3 months from the deadline for serialization and tracing of all drugs.Continue reading Russia: Rationality Makes An Appearance at the 11th Hour. Will It Matter?
Every year I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar. It’s the one event in the US that is attended by everyone connected with pharma serialization and traceability, including those from manufacturers, 3PLs, repackagers, wholesale distributors, dispensers and solution providers. In that one time and place I can get answers to burning questions about what is going on in the industry and a sense for what people are thinking about a wide range of issues that appear here in RxTrace. The sessions are helpful, but the real goldmine are the hallway conversations. Of course, I’ve written about this before (see “2014 Fall Conference Season Preview” and “Terminology: Track and Trace, and Pedigree”).Continue reading Next Week’s HDA Traceability Seminar