TLDR DSCSA | January 2025 ??
The most interesting DSCSA stories and news for the month of January.
Learn about the FDA’s enforcement of DSCSA regulations, leadership changes at the FDA, and scrutiny over SARS-CoV-2 manufacturers' compliance with safety standards. Discover pharmacy technology advancements driving DSCSA compliance and recent corporate divestitures shaping the industry. Additionally, explore new legislation tackling PBM monopolies and key DSCSA compliance deadlines for 2025.
Thanks for reading,
Daniel Kraciun / Chief Marketing Officer @ Trust.med
?? Industry & GOV
?TLDR: With the FDA's phased enforcement of the Drug Supply Chain Security Act (DSCSA) set to begin in May 2025, compliance bottlenecks such as outdated technology, cost constraints, and data inconsistencies persist, particularly among smaller manufacturers. Noncompliance risks include fines, product recalls, and reputational damage, though the FDA may offer waivers for critical-need drugs. While another extension seems unlikely, manufacturers must prioritize data governance and interoperability solutions to avoid penalties and supply chain disruptions.
?TLDR: Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research (CDER) announced her departure. The transition occurs as the FDA prepares for new leadership under Martin Makary and faces upcoming negotiations on user fee agreements. These changes signal potential shifts in FDA leadership dynamics and regulatory approaches.
?TLDR: An analysis highlights significant lapses in compliance with patient safety regulations by SARS-CoV-2 vaccine manufacturers. Despite stringent global standards like GMP and GDP, gaps in traceability and adherence to manufacturing rules, especially during clinical trials, are cited as critical vulnerabilities. The article critiques the limitations of existing legislation, emphasizing the need for robust upstream supply chain oversight to prevent future public health risks.
领英推荐
?TLDR: The Drug Supply Chain Security Act (DSCSA) has set new compliance deadlines for manufacturers, distributors, and dispensers following the end of the stabilization period in 2024. Temporary exemptions for certain trading partners aim to ensure uninterrupted product distribution, with deadlines extending into late 2025.
??Pharmacy
?TLDR: The PBM Act aims to address conflicts of interest within vertically integrated pharmacy benefit managers (PBMs) by prohibiting their parent companies from owning pharmacy businesses. With provisions for divestitures and oversight, the legislation seeks to reduce anti-competitive practices, lower costs for patients, and protect independent pharmacies, especially in underserved areas.
?TLDR: Inmar Intelligence has sold its Supply Chain Solutions division to DHL Supply Chain, allowing the company to prioritize innovation in Healthcare and Martech. The move strengthens its pharmaceutical reverse distribution services, including Rx Returns and DSCSA compliance, while expanding AI-driven media and digital incentive solutions for retailers. The divestiture underscores Inmar's commitment to enhancing safety, compliance, and consumer engagement in rapidly evolving markets.
??? Technology
?TLDR: Pearson Medical Technologies has released technology and a rules-based algorithms to enhance pharmacy workflows. The software extracts DSCSA barcode data, including unique identifiers, expiration dates, and lot numbers, improving labeling accuracy and safety. Designed for diverse packaging needs, m:Print? integrates with Pearson’s iPack? Rx Unit Dose Packager, offering a versatile solution for medication repackagers and hospital pharmacies to meet DSCSA compliance while boosting efficiency and patient safety.