US Pharmacopeia

The FDA recently announced a Class II recall for more than 7,000 bottles of the antidepressant duloxetine (brand name: Cymbalta) due to the presence of nitrosamines a type of impurity in pharmaceuticals that can potentially increase cancer risk with long-term exposure. The last month saw additional recalls of medications also due to traces of nitrosamine-related impurities according to reports. Nitrosamine drug substance-related impurities (NDSRIs) are a class of impurities that can be formed in a variety of ways during a drug’s development and manufacture – from raw ingredients to manufacturing, packaging, and storage. The pharmaceutical industry and regulators are working to limit the presence of nitrosamines to ensure a safe medicine supply. Regulatory agencies around the world, including the U.S. FDA, work with manufacturers to establish safe levels of nitrosamines in medicines to prevent the need for recalls, which take place when unacceptable levels of the impurities are discovered in products. If you or someone you know is taking duloxetine, consult your healthcare provider for guidance. Read the infographic below ⤵️ to learn more about nitrosamines, what other medications have been recalled due to the impurities, and what USP is doing to help as industry prepares for an Aug 1, 2025 deadline to finalize confirmatory testing for NDSRIs in drug products and submit required changes to drug applications. 👉 Share this post to help others stay informed. #USPScience #FDARecall #duloxetine #nitrosamines

At US Pharmacopeia, we believe that true progress thrives on inclusivity. As we recently celebrated the International Day for People with Disabilities, we reaffirm our dedication to creating an environment where everyone—regardless of ability—can lead, grow, and thrive. Inclusivity isn’t just a value at USP; it’s embedded in our policies and culture. Through initiatives like our "Diverse Minds & Bodies Affinity Group", we provide a platform for individuals with disabilities to connect, advocate, and lead. This group plays a pivotal role in fostering a culture of support, mentorship, and collaboration, ensuring that every voice is heard and every perspective is valued. We’re proud of the progress we’ve made and remain dedicated to advancing our efforts. By amplifying the leadership and contributions of persons with disabilities, we move closer to a future that is truly inclusive, sustainable, and enriched by diverse talents. Join us in shaping this future! Explore opportunities with us here: https://usp.jobs/

Recently, the leadership teams of US Pharmacopeia and Biotechnology Industry Research Assistance Council (BIRAC) came together to further our shared vision for advancing India's biomanufacturing sector. This pivotal meeting included Ronald Piervincenzi, CEO, USP, Jaap V. , CSO, USP along with Dr. Jitender Kumar, MD, BIRAC, and Dr. Sonia Gandhi, Deputy General Manager & Head, Regulatory Affairs & Policy Advocacy, BIRAC. USP and BIRAC officially completed the signing of the Letter of Intent, a significant milestone first announced at Global Bio India 2024. This collaboration underscores a shared vision to build capabilities in biomanufacturing, enhancing the quality of biopharmaceuticals and drive innovation in India's biomanufacturing ecosystem. We are excited to continue this partnership and work together to create impactful solutions that foster sustainable growth in the biopharmaceutical landscape.

Happy Holidays from USP! We wish you the best this holiday season and a happy, healthy new year.

#DYK: USP's Ingredient Verification Program for Dietary Ingredients can help suppliers mitigate risks to their #SupplyChain and demonstrate quality to their customers. USP's Ingredient Verification Program for Dietary Ingredients is a comprehensive, multi-step process that includes auditing manufacturing sites for conformance with current Good Manufacturing Practices (cGMPs), reviewing #QualityControl and manufacturing (QCM) product documentation, and testing ingredient samples in USP laboratories. Learn more: https://ow.ly/UF3t50UtA7S

Rigorous quality control is essential to meet regulatory standards and ensure vaccine quality. When it comes to squalene, a key component in certain adjuvants, pharmaceutical manufacturers need reliable analytical standards and methods for assessing squalene’s identity, quantity, and purity. USP’s squalene analytical reference material (ARM) has undergone extensive characterization and evaluation, making it suitable for multiple analytical applications. Learn why manufacturers trust it for their analytical testing needs. Read our new Squalene ARM Application Note for more ➡️: https://ow.ly/5wK850UsVJQ

The USAID-funded PQM+ program is partnering with Rwanda Medical Supply Ltd, a public pharmaceutical procuring agency for health commodities, to provide technical support to implement a robust Quality Management System, and help the organization achieve ISO 9001:2015 certification. These efforts will enhance the credibility and reputation of RMS Ltd on the global market and help to ensure the quality of medicines in #Rwanda. #HealthSystems

Recently, USP was honored to host a distinguished Nepali delegation at our headquarters in Rockville, Maryland. The group included government officials, representatives from the U.S. Agency for International Development (USAID) Nepal office and USAID PSM project, and the USAID-funded Promoting the Quality of Medicines Plus (PQM+) program’s Nepal colleagues. The delegation engaged in meaningful discussions with USAID colleagues about PQM+ Nepal initiatives and areas of support. They met with USP leadership, including CEO Ronald Piervincenzi and Global Health and Manufacturing Services leads, generating informative dialogue relating to ongoing PQM+ activities and the potential for additional support. The delegates also had an opportunity to tour and learn more about USP’ labs onsite. Global Standards 1 (GS1) colleagues conducted a training session on traceability, supply chain visibility, and barcoding, featuring real-world examples and a mock simulation relevant to the Nepal pharmaceutical landscape, including a site visit. The visit concluded with a bilateral, government-level meeting hosted by the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) to discuss areas of potential collaboration. We look forward to continuing our collaboration in the future! #ProudToBeUSP #GlobalHealth

Seeking feedback on the below proposed USP standards for dietary supplements! New Monographs: Aronia melanocarpa Fruit Dry Extract Cordyceps militaris Fruiting Body Cordyceps militaris Fruiting Body Powder Pomegranate Fruit Dry Extract Monograph Revisions: Bitter Orange Fruit Flavonoids Dry Extract Bromelain Papain meso-Zeaxanthin Submit your comments by January 31, 2025: https://ow.ly/ZVFW50UpcPb

We work to ensure quality #MedicalDevices for patients no matter where they live. Last week, USAID's PQM+ facilitated trainings with #Nepal's Department of Drug Administration (DDA) to start regulating health technology products (HTPs), including medical & lab equipment, and share best practices. Learn more about our work in Nepal: https://ow.ly/4Qcb50Uq9P4