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