The FDA recently emphasized the urgent need for compliance with the Drug Supply Chain Security Act (DSCSA), impacting the pharmaceutical industry significantly. At the 2024 FDLI Annual Conference, Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research (CDER), confirmed that there will be no further extensions to the compliance deadline. This announcement marks a critical step in the FDA’s ongoing efforts to secure the pharmaceutical supply chain.
Continue reading FDA’s Firm Stance on DSCSA Compliance: No More DelaysTag Archives: DSCSA
FDA Official Will not extend the 2023 deadline
Deadline will not be extended
As reported by the Regulatory Focus, the FDA will not delay the interoperability deadline for the DSCSA 2023 deadline. You can for sure group the saleable returns requirements as well. The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have a full interoperable electronic track and trace system in place by 2023.
Continue reading FDA Official Will not extend the 2023 deadlineThe 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).
Continue reading The FDA’s New Guidance for 2021 Explained2 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.
Continue reading 2 Organizations You Need to Join to Get Ready for the DSCSA Phase IIEPCIS 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.”
Continue reading EPCIS GUIDE for your organizationImpact 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.
Continue reading Impact of COVID-19 on DSCSA ImplementationDrug 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 knowFDA Provides Guidance on DSCSA Exemptions for Covid-19 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