US Pharmacopeia

The number of drug shortages has declined, but existing shortages continue to last longer as underlying supply chain vulnerabilities grow.    In USP's 2025 Annual Drug Shortage Report, USP's Marissa Bane Reigelman (Malta), MPP, and Erkan Duman, Ph.D., explore why strengthening supply chain resilience can help ensure millions of patients have reliable access to essential medicines.    Read more ⤵️ 

Greater availability of biosimilars starts with scientific alignment. Public standards can help establish quality benchmarks for more consistent development and regulatory review, reducing complexity and supporting more efficient pathways to patient access. In consultations with 30 organizations—including 14 national regulatory agencies and 11 biologics manufacturers—USP heard a clear message: regulators want trusted, neutral reference points and flexible standards that streamline analytical review across laboratories and agencies. Read more about how emerging standards for biologics can help align manufacturers and regulators to accelerate market access in Anthony Lakavage's byline in DIA Global Forum: https://lnkd.in/eSSM2ueP

USP launched a new online store that provides a more streamlined experience for users. The USP Store is a proven, reliable resource of standards and solutions. By introducing improved features and streamlined profile creation, we reflect how teams work in practice, empowering independent, accurate decisions across the ordering and purchasing process. We want to make it easier for users to move through the platform with clarity and confidence, supporting faster access to standards needed across the product lifecycle. While the experience has evolved, the trusted standards, solutions, and offerings our users already rely on remain the same. Explore the new USP Store: https://lnkd.in/eKMvJVbW

For the first time, European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Japanese Pharmacopoeia, and USP have launched a trilateral prospective harmonization project focused on standards for Osimertinib Mesylate and Osimertinib Tablets, treatments used for lung cancer. Building on more than 30 years of collaboration, this historic initiative expands harmonization efforts beyond excipients and general chapters to include drug substances and finished dosage forms. By working toward aligned standards, the three pharmacopeias aim to support more consistent quality expectations, reduce duplicative testing and regulatory burden for manufacturers, and advance greater convergence across regulatory regions. Importantly, this work supports a shared goal: helping ensure access to quality medicines for patients around the world. Read more about the harmonization project ⤵️

Drug shortages can cause treatment delays, changes to care plans, and higher risk of medication errors, impacting patients and the healthcare professionals who care for them. While the number of active drug shortages has declined, the vulnerabilities driving them remain, including geographic concentration within the medicine supply chain. In a new National Association of Boards of Pharmacy article, USP Principal Scientist Misti Spann, PharmD, uses USP's latest Annual Drug Shortages Report to show why building medicine supply chain resilience requires looking beyond finished medicines to identify hidden supply risks. Read more: https://lnkd.in/eE-94ff4 

Last week, at Angels for Change #SummitONE2026, USP joined supply chain leaders, healthcare experts, policymakers, and patients in discussions on innovative models and systemic solutions to prevent and mitigate drug shortages. The conference highlighted a shared commitment from public- and private-sector stakeholders to build a better path forward. Drug shortages continue to harm patients, communities, and the entire healthcare system, with the average drug shortage now exceeding 5 years in duration. Systemic, data-driven solutions like improving coordination up and down the supply chain, increasing visibility into potential disruptions, identifying vulnerable medicines, incentivizing efficiency, and bolstering manufacturing capacity will help build a more resilient medicines supply chain. Learn more about how USP collaborates with Angels for Change and other partners to help address drug shortages: https://lnkd.in/eHBwJiJk

Last week in Rockville and this week in Frederick, USP welcomed employees and their families to Take Your Kids to Work Day. This year’s theme, Future Innovators, highlighted the curiosity, creativity, and problem-solving that drive USP’s mission. Throughout the day, employees’ families got a closer look at how USP helps advance the quality of medicines, dietary supplements, and food ingredients worldwide. Thank you to everyone who helped make the day an engaging and memorable experience for our future innovators. 

The USP–NF public comment process brings together scientific expertise from across industry, academia, regulatory agencies, and healthcare. USP publishes comment summaries with Expert Committee responses when proposals are approved via ballot and subsequently published. This comment cycle features proposed USP–NF standards spanning a range of topics, including dietary supplements and dietary ingredients. These proposals reflect the important role stakeholder input plays in strengthening public standards. Learn more: https://lnkd.in/dxTuTsJ 

Last week USP partnered with Indonesia's Food and Drug Authority (BPOM) to co-host the USP–BPOM Joint Symposium and convene USP's 6th Annual Asia-Pacific Regional Chapter Meeting in Jakarta. These events brought together regulators, industry leaders, academics, World Health Organization representatives, and other international partners from across the region to exchange knowledge, strengthen partnerships, and advance regulatory excellence. Through engaging panel discussions and collaboration among participants, the events reinforced a shared commitment to advancing regulatory science, promoting quality standards, and supporting access to quality medicines across the Asia-Pacific region. Thank you to BPOM and to all the experts and partners who shared their knowledge and perspectives throughout the week. USP looks forward to continuing this collaboration to advance regulatory systems and help improve access to quality medicines across the region. 

USP's 2025 Annual Drug Shortages Report found that shortages declined by 23% in 2025 but are lasting longer than ever, averaging more than five years. Product discontinuations also rose by 60% from 2024 to 2025, highlighting continued vulnerabilities in the pharmaceutical supply chain. To better understand what is driving these trends and how manufacturers can build more resilient supply chains, PharmTech (Pharmaceutical Technology) interviewed Gabriela Grasa Mannino, USP's Senior Director of Advanced Supply Chain Solutions. Gabriela shares insights on the structural vulnerabilities behind today's drug shortages, the four key drivers of supply chain risk, and how quality standards, AI, and stronger manufacturing systems can help strengthen medicine supply. Read more: https://lnkd.in/gYU3-Bwx