EPCIS GUIDE for your organization

*NOTE – We are including a Free Trading Partner Integration template for you to download at the end of this article.

The 2023 DSCSA requirement looms in the near future and pharma companies are frantically working together to create and implement the technological goals that create the interoperable system by November 27, 2023. To achieve the three areas of interoperability as defined by the PDSA—exchange, verification, and tracing—these companies must also land on a common informational framework. 

In other words, to create a system that allows for the DSCSA vision of “fully interoperable, electronic tracing of products at the package level,” the industry needs to pick a common standard and use it throughout pharma. I discuss the challenges in my previous article: Drug Supply Chain Security Act, Phase II: Here’s what you MUST know.

Gary Lerner, the president at Gateway Checker Corporation, explained what it would take to make this happen. In short: “Capturing and exchanging information at this level of specificity requires a common information framework.”

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Impact of COVID-19 on DSCSA Implementation

Before the pandemic struck, the pharma industry was working feverishly to implement and enforce all the requirements of the DSCSA, especially the Phase II requirements scheduled for November of 2023. When COVID-19 dramatically changed the business landscape, the implementation became even more of an uphill battle, with both time and the pandemic acting as a cause of concern. 

In today’s post, we will look at COVID-19 and its impact on the DSCSA: from the FDA loosening some of the guidelines to the different areas of the DSCSA that are being impacted the most. If we can understand the relationship between these two, we can have a better grasp of realistic understandings and the best course of action moving forward.

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Why the FDA Extended The Saleable Returns Verification from 2020 to 2023

In 2020, most things did not go as planned. Considering the overwhelming impact of the worldwide pandemic, the pharmaceutical industry was far from immune to last year’s instability.

One of the major changes came with the Saleable Returns Verification’s extension. Despite being originally scheduled for a 2020 enactment, the FDA recently announced their plan to extend, yet again, the Saleable Returns Verification enforcement until 2023.

What does this really mean? Well the FDA won’t enforce it. So should you not care? It’s not that simple.

Legal liability

Remember, the law is the law. So the Saleable Returns Verifcation did become a requirement of the law this past November 27th 2020.

Continue reading Why the FDA Extended The Saleable Returns Verification from 2020 to 2023

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

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

The Future of RxTrace Has Arrived

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 The Future of RxTrace Has Arrived

FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE

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 FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE

DSCSA Exemption For Public Health Emergencies

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 DSCSA Exemption For Public Health Emergencies

Sponsored: 2021 UDI Conference Has Been Rescheduled

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.

Continue reading Sponsored: 2021 UDI Conference Has Been Rescheduled

…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.
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