Drug Supply Chain Security Act, Phase II: Here’s what you MUST know

January 25, 2021 Christian Souza

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:

Continue reading →

RxTrace

The Future of RxTrace Has Arrived

November 18, 2020 Dirk A. Rodgers 9 Comments

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.

Continue reading →

DSCSA

FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE

May 7, 2020 Dirk Rodgers 2 Comments

FDA explains EUAs under a PHE

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 →

DSCSA

DSCSA Exemption For Public Health Emergencies

April 20, 2020 Dirk Rodgers

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 is only the second public health emergency with nationwide scale announced in at least the last 20 years. The first was for the opioid crisis. The intent of these declarations is to lower the liability exposure to companies helping to create, distribute and administer countermeasures aimed at ending the emergency. Let’s take a closer look at the effect of the Covid-19 PHE on the DSCSA and companies in the US pharma supply chain.

Continue reading →

UDI

ACTION REQUIRED: RxTrace Subscriber Update

February 17, 2020 Dirk Rodgers

To tell which type of notification email you are receiving, check the bottom line for the text “Email subscriptions powered by FeedBlitz. If you don’t see it, you are probably receiving the new WordPress notification emails. If you are confused, contact me.

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 →

Anti-counterfeiting, Traceability

WHO Publishes Draft Policy Brief for Medicines Traceability Regulations

February 11, 2020 Dirk Rodgers

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.

Continue reading →

FMD

What Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know?

February 3, 2020 Dirk Rodgers

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 →

RxTrace

Drug Supply Chain Security Act, Phase II: Here’s what you MUST know

The Future of RxTrace Has Arrived

FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE

DSCSA Exemption For Public Health Emergencies

Sponsored: 2021 UDI Conference Has Been Rescheduled

ACTION REQUIRED: RxTrace Subscriber Update

WHO Publishes Draft Policy Brief for Medicines Traceability Regulations

What Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know?

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance