With the final DSCSA exemption deadline looming in May 2025, pharmaceutical manufacturers must act now to comply with the FDA’s interoperability, serialization, and traceability mandates. Non-compliance isn’t just a regulatory headache—it can cause severe disruptions, including halted product sales, costly recalls, and damaged supply chain relationships.
Continue reading DSCSA Compliance: Essential Steps for ManufacturersAll posts by Christian Souza
Regulatory Freeze Under the New Trump Administration: Implications for DSCSA Compliance
The Drug Supply Chain Security Act (DSCSA) compliance deadlines are fast approaching. Despite the political landscape’s recent shifts, these deadlines remain firmly in place. The regulatory freeze introduced by the Trump administration in January 2025 has generated discussions, but it does not alter these legally mandated timelines. Businesses must continue their preparations to ensure compliance.
Countdown to May 27th: Manufacturers & Repackagers Prepare for DSCSA
The clock is ticking for pharmaceutical manufacturers and repackagers. By May 27, 2025, they must comply with the Drug Supply Chain Security Act (DSCSA) requirements, a crucial step toward achieving transparency, safety, and accountability within the U.S. drug supply chain. This deadline marks a critical step in creating an interoperable electronic system to track and trace prescription drugs throughout their lifecycle. For those in the pharmaceutical supply chain, the time to act is now.
DSCSA Exemptions: What You Need to Know for Compliance
The Drug Supply Chain Security Act (DSCSA) is designed to enhance the safety and traceability of pharmaceutical products. Recent FDA guidance, issued on October 9, 2024, introduced temporary exemptions from certain DSCSA requirements, offering businesses more time to comply. DSCSA Exemptions: What You Need to Know for Compliance is essential for understanding these exemptions’ implications and ensuring companies take the necessary steps to remain on track with compliance efforts.
FDA’s Firm Stance on DSCSA Compliance: No More Delays
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 DelaysFDA 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 ExplainedFDA’s Food Safety Modernization Act (FSMA), Explained
One of the most important things for a country to safeguard is the health and safety of its residents. Hazards don’t always arrive in plain sight and are most often hidden in things we trust and consume on a daily basis. The biggest example of this is the food we eat.
Food has the ability to nourish us and provide us with the energy to thrive in our existence, but it can also severely damage our health if not mandated properly. This is the main reason why the FDA’s Food Safety Modernization Act (FSMA) was enacted in 2011 by President Obama.
The specifics of the act are complicated, and the nature of the subject matter requires extensive regulations to be upheld. In this article, we’ll give you an overview of everything worth knowing about the FSMA guidelines. We’ll show you the importance of food regulation standards, we’ll get into each aspect of the FSMA in more detail and we’ll end with what’s changed for 2021.
Continue reading FDA’s Food Safety Modernization Act (FSMA), Explained