As 2020 transitioned to 2021, we took another step closer toward the implementation of 2023 Drug Supply Chain Security Act, Phase II. From manufacturers to wholesalers, pharmacies and other stakeholders, many uncertainties are swirling around the subject, so today we are writing to try to dispel some of the concern.
Let’s start with an overview of DSCSA Phase II and its components.
DSCSA Phase II, which goes into effect on November 27, 2023, is intended to roll out the electronic tracing of products at the package level. To make this happen, the 2023 requirements are comprised of three specific parts, and they are as follows:
If you are a frequent RxTrace reader, you might have notice that I haven’t been writing for a while. No, I haven’t been sick with Covid-19 (not yet anyway) or sick with anything else. No, I didn’t run for elective office in the recent general election. Any other theories? In reality, I intended to take the month of March off as a well-deserved vacation, and I did that. Then, when Covid-19 hit, there wasn’t much to write about, mainly because of the uncertainty. After that, I got busy with house remodeling projects and consulting. And now I am announcing my retirement from most (maybe not all) consulting, and from RxTrace.
On March 10, 2020, Alex M. Azar II, Secretary of Health and Human Services of the US government, declared a public health emergency (PHE) under Section 319F of the Public Health Service Act “…to provide liability immunity for activities related to medical countermeasures against COVID-19.” This action immediately opened an exemption embedded in the Drug Supply Chain Security Act (DSCSA) for the “covered persons” performing the “covered countermeasures” aimed at the specific “threat” in the covered “geographic area”, for the identified “population” for the “effective time period” specifically identified in the declaration.
This event has been rescheduled to April 12-13, 2021.
Calling all medical device manufacturers, distributors, GPO’s, Providers, and healthcare industry stakeholders to make plans now to be in Baltimore in ???! The 12th annual UDI Conference continues to be the platform for you to stay informed about the latest developments in UDI implementation, enabling technology, regulatory updates, Provider momentum, and Global expansion.
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.
Late last month the World Health Organization (WHO) published a draft “policy brief” for comments by February 28, 2020. The draft is aimed at regulators of medicines around the world who might be considering the development of new medicines traceability mandates. That pool of countries shrinks each year as more and more new mandates are announced, but considering the wide variations in the quality of the existing regulations, guidance aimed at those who would create new mandates is welcome. Let’s take a look at the draft.
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.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of RxTrace. The material contained in RxTrace is not legal advice. The writers of RxTrace are not lawyers. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than RxTrace.