Category Archives: DSCSA

DSCSA, FDA

The FDA’s New Guidance for 2021 Explained

As the premier regulatory body for ingestible products in the United States, the FDA (Food and Drug Administration) is responsible for safeguarding public health through safety measures, guidance, and regulations. The importance of the FDA’s job cannot be stressed enough, and in the current global health crisis we find ourselves in, this responsibility is even more critical.

The FDA’s annual guidance schedule is often more aspirational than strictly practical, but it does a good job in providing useful insights into what areas the FDA’s CDER (Center for Drug Evaluation and Research) has given priority for that particular year. 

You can find updated lists for the FDA’s guidance for 2021 here. In this article, we’ll focus on the guidance as it relates to the DSCSA (Drug Supply Chain Security Act).

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DSCSA, HDA, PDG

2 Organizations You Need to Join to Get Ready for the DSCSA Phase II

If you are a pharmaceutical company serious about meeting the requirements of Phase II of the DSCSA, there are two organizations you must join. 

The first is the Partnership for DSCSA Governance, or the PDG. It is an organization formed by manufacturers, wholesalers, dispensers, and solution providers that are working to solve the interoperability requirements for the DSCSA for 2023. The PDG is a 501(c)(6) nonprofit business association requiring a yearly membership fee to join. 

The other is the Healthcare Distribution Alliance, or HDA, which is a long-running organization that represents many members of the pharma supply chain in a quest to advocate for public policy that supports patient access to medical products through safe, efficient, and effective distribution. The HDA also requires a yearly membership fee.

Today’s post will look at both organizations, profile what they do, and then let you know why joining them is crucial for getting the most out of the DSCSA.

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DSCSA, EPCIS

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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COVID-19, DSCSA, FDA

Impact of COVID-19 on DSCSA Implementation

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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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DSCSA, FDA, Saleable Returns Verification

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

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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.

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DSCSA, EDDS, EPCIS

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:

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DSCSA

FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE

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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.

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DSCSA

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.

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