FDA Update on DSCSA Deadline : What Should Manufacturers Do Until 2024?
A milestone in enhancing the security of the U.S. drug supply chain, the Drug Supply Chain Security Act (DSCSA), recently had an update regarding the compliance deadline. According to guidance issued by the United States Food and Drug Administration (US FDA) in August, the implementation of the core requirements of DSCSA has been postponed from November 2023 to November 2024. However, the FDA described this as not an extension but rather a flexibility provided to stabilize electronic systems and the tracking process.
Let’s Recall DSCSA Compliance:
The drug supply chain, like all supply chains, has become increasingly complex, especially due to the growth of the population. The production, storage, distribution, and delivery of drugs at various stages increase the risk of counterfeiting. Therefore, the Drug Supply Chain Security Act (DSCSA), which was enacted in the United States in 2013, is an important law aimed at enhancing the security of the drug supply chain. This law addresses the benefits it provides to drug manufacturers, all stakeholders in the supply chain, and the public.
What Does the “Stabilization Period” Mean?
We have discussed the details of DSCSA in previous articles. In our first article, we provided the implementation timeline of DSCSA, and in subsequent articles, we discussed cost-effective VISIOTT TPS solutions that are fully compliant with DSCSA requirements. In this article, we will focus on why DSCSA stabilization period has arrived and how manufacturers can make the most of this period.
The FDA explained that the reason for this additional period is the need for supply chain stakeholders to be in full compliance. It is clear that supply chain stakeholders are not equally prepared for DSCSA, and these concerns have been raised throughout the process. In short, the inability to complete preparations and meet compliance requirements led to a one-year postponement for DSCSA.
Always Moving Forward with DSCSA Requirements:
When traceability requirements are determined by regulation, supply chain stakeholders take action to meet these requirements. Some suppliers achieve compliance quickly, while others may stagger it for various reasons.
For the United States, stepping back from DSCSA requirements, which have spread across a wide spectrum of the supply chain, would result in wasted investments, financial losses, and an inability to keep up with progress – something a country like the United States would never allow.
The FDA emphasized in its guidance that this one-year extension does not mean a departure from traceability, and supply chain actors should continue to make strong efforts to implement the enhanced drug distribution security requirements:
“The FDA strongly encourages trading partners to continue their efforts to implement the enhanced drug distribution security requirements.”
Manufacturers should use this time to collaborate with companies that can fully achieve compliance. Supply chain stakeholders should seek professional assistance in the field of traceability to make the stabilization process efficient. So, who can be consulted in this regard? This is where VISIOTT TPS, which develops compliance solutions for regulations worldwide, including DSCSA, comes into play.
What Can We Do for You?
VISIOTT TPS, with its strength as a leader in traceable packaging technologies, develops solutions for many countries, including the United States. Our software solutions developed to be compliant with DSCSA include notification, operation management, and reporting features. With software solutions developed following ANSI ISA 95 standards, you can achieve maximum data integrity and efficiency with minimum hardware resources. Our software is already integrated with over 100 popular ERP, MES, and Level 4 systems.
You can examine VISIOTT TPS Solutions that can successfully navigate the stabilization period in the U.S. drug supply chain and meet all your needs, including aggregation.
Notification and Management Operations According to DSCSA Requirements
VISIOTT TPS software developed with consideration for all the needs of the American pharmaceutical industry, performs station management and notification operations according to DSCSA requirements. With VISIOTT TPS software developed in accordance with the ANSI ISA 95 standard, you can achieve maximum data integrity and efficiency with minimum hardware resources. VISIOTT TPS software easily integrates with ERP, MES, and Level 4 systems.
VISIOTT TPS Line Manager can communicate and control in real-time with multiple hardware. Its configurable structure allows for easy addition of new hardware. VISIOTT TPS Line Manager doesn’t need a Plant Manager (Level 3) data source for operation continuity, but it has been designed to quickly report results to the Plant Manager software.
VISIOTT TPS Plant Manager is an innovative software that manages the entire traceability process from a single screen. The main function of VISIOTT TPS Plant Manager is to assign work orders to lines based on information received from any EPCIS server or Level 4 solution, and to store serialization and aggregation data when the work order is complete. With the ability to track serial numbers throughout their lifecycle, VISIOTT TPS Plant Manager makes it easier to monitor traceability operations.
VISIOTT TPS Never Leaves You Alone
VISIOTT TPS prioritizes its customers’ expectations in all stages, from production to sales, from installation to service. Communication takes place quickly thanks to its sales and service network located in many parts of the world. VISIOTT TPS’s spare parts service is long-lasting.
VISIOTT TPS provides 7/24 post-sales support to its customers and continues to serve in accordance with DSCSA requirements. You can contact us immediately to get information about VISIOTT TPS and ask your questions.