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?
2020 will also be a year of some important changes for RxTrace. As many of you know, I have been running RxTrace under a paid subscription model for a number of years now. The income that model generated helped pay for my membership in GS1 Healthcare, which allowed me to monitor all pharma traceability regulations around the world. That subscription model will end in March this year, and with the end of paid subscriptions, RxTrace will once again become open and available to everyone. All paid subscriptions have been prorated since March 2019 so that they will end in March 2020. Automatic re-subscriptions beyond February have been turned off.
This will lead to several other changes. Because I will no longer receive any compensation for the efforts put into the site, I will no longer be able to cover regulations outside of the United States. Going forward, RxTrace will mainly only cover developments relating to the DSCSA. With the reduction in scope I will also write less frequently. To reduce the costs of maintaining the site, I will look for an alternative to the Feedblitz email notification service that I have been using to send out the new essay notification emails each time I post. More than likely, that will require everyone wishing to continue monitoring RxTrace through email notifications to resubscribe. I will let you know well in advance of that change so you know what to do if you want to continue monitoring. One benefit of opening the site back up to all-access is that I will be able to switch around some of the WordPress plug-ins I use. One of those will actually speed up the performance of the site. I’m looking forward to that.
I’d like to thank everyone who has supported RxTrace over the years and I hope you continue to enjoy reading throughout 2020 and beyond. I continue to enjoy researching and writing. I continue to help clients understand the DSCSA and what they need to do to be compliant. I may do some public writing on behalf of a client in the future (potentially with the same global coverage that will be eliminated from RxTrace in March) so watch for that. I hope to closely monitor the activities of the new DSCSA Industry Governance group that is finally getting started (more on that in the coming weeks). And, of course, I will cover here in RxTrace FDA, HDA and the public postings of GS1 US and any other organization that influences the industry response to the DSCSA.
Stay tuned. Thanks again,