US Pharmacopeia

Does your “complex” medicine have a generic alternative? If not, have you ever wondered why? Generic medicines account for roughly 90% of prescriptions filled in the US, making it easier for patients to access essential and lifesaving treatments. Complex medicines, a distinct regulatory category as defined by FDA are less likely to have generic alternatives and thus can be less available to patients compared to non-complex products. While roughly 25% of all FDA-approved drugs in FY22 were “complex”, only 13% of generics approved were complex. Patients around the world rely on complex generics, particularly for chronic conditions such as asthma, osteoporosis, and schizophrenia. Injectables like epinephrin (Auvi-Q, EpiPen) and enoxaparin are among the most widely used complex generics. Unique scientific and regulatory challenges make these products more costly to develop and less likely to have clear regulatory pathways. Read “Complex generics: The need and challenges" by Prabhakar Reddy, to learn more ➡️: https://ow.ly/RV0u50T4iMn

Drug shortages are everywhere. We speak with Vimala Raghavendran, Vice President, Informatics Product Development at the US Pharmacopeia (USP) to get the full picture of what’s going on in pharma’s supply chains. #drugshortages #pharmaceutical https://ow.ly/pavs50T8zEI

Register today for the upcoming USAID-funded PQM+ webinar series, “Exploring Current eCTD and eQMS Software Solutions”. This two-part series, intended for regulatory authorities and pharmaceutical industry regulatory affairs professionals, will provide an overview of eCTD and eQMS software on the market and offer guidance on selecting the right software for your organization. Join us at 7am – 9am ET on September 18th and 19th! ⤵ eCTD registration link: https://ow.ly/p5qm50T8Th9 eQMS registration link: https://ow.ly/2a3l50T8Th7 #HealthSystems

Congrats to Swiss Pharma Nigeria Limited in #Nigeria & Mepro Pharmaceuticals in #India for achieving WHO approval for two essential medicines in the fight against #malaria & neglected tropical diseases, which are poised to make tremendous impact on the health of women and children worldwide, thanks to USAID support through PQM+. Learn more https://ow.ly/SewC50TbCE2 #NTDs

Are you interested in the latest developments and best practices in endotoxin and pyrogen testing? Don't miss this USP onsite workshop! Key topics to be discussed include: 1️⃣ Alternative Methods to <85> and <151>: Understand the history of USP Endotoxin and Pyrogen Testing and explore advanced techniques for Bacterial Endotoxins and Rabbit Pyrogen Tests. 2️⃣ New <86> Bacterial Endotoxins Test Using Recombinant Reagents: Learn about sustainable and ethical alternatives to traditional methods. 3️⃣ New Lot Release of USP Endotoxin Reference Standard: Get the latest information on reference standards. https://ow.ly/36wo50Ta3mc #USPScience #ReferenceStandards

USP was proud to host the delegation from the Economic Development Administration at our Advanced Manufacturing Technology Lab last week as part of their site visit to the Alliance for Building Better Medicine's Richmond-Petersburg Advanced Pharmaceutical Manufacturing Tech Hub. The visit showcased the work the hub is doing to facilitate domestic production of safe, quality, and affordable medicines. We look forward to contributing to workforce development, increasing diversity in STEM, innovation, and the continued growth of a revitalized API industry in the U.S. based on the significant experience, leadership, and expertise among the Alliance members.

What role will US Pharmacopeia Expert Volunteers play in advancing the future of medicine and global #PublicHealth? USP CEO Ronald Piervincenzi has the answer. Hear more from Ron about why our global volunteer network will be central to USP’s efforts on issues ranging from supply chain resiliency to access to quality-assured medicines. And get inspired to amplify your impact as a #USPExpertVolunteer: Bit.ly/USPExpertVolunteer

Celebrating Excellence in Science: The Expert Volunteer Scientists at USP At US Pharmacopeia, our mission to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods is driven by the remarkable contributions of our Expert Volunteer Scientists. These dedicated individuals are at the forefront of advancing scientific knowledge and innovation, dedicating their expertise to create a healthier world. One shining example of such dedication is Kim HuynhBa, who serves as the Chair of one of our pivotal Expert Committees as well as on the Council of Experts. Kim’s leadership and deep expertise in pharmaceutical sciences make her a cornerstone of our scientific process. Her upcoming engagement at American Association of Pharmaceutical Scientists (AAPS) | @aapscomms Pharmsci360 in October, where she will speak about data integrity, highlights her role as a thought leader in the pharmaceutical field. Her contributions not only enhance the integrity and quality of pharmaceutical practices but also foster the spread of scientific knowledge across the globe. The work of our volunteers like Kim Huynhbah significantly impacts the scientific community, setting standards that assure the quality of medicine and patient safety worldwide. If you are looking to make a substantial impact in the scientific and healthcare communities, and wish to be in the company of esteemed experts like Kim, consider volunteering with USP. https://lnkd.in/dNGXnQ8g By joining USP as a volunteer, you will collaborate with a network of professionals dedicated to building a legacy of quality health standards. It’s more than a contribution—it’s a commitment to making a difference in the lives of millions around the world. For those interested in volunteering or learning more about our impactful work, please visit our website and discover how your expertise can help shape the future of global health standards. Join us, and be a part of setting standards that protect and improve human health everywhere. And let’s give a round of applause to Kim for her continued commitment to making the world of science better every day!

Clear and accessible information in prescription drug leaflets is critical to help providers counsel patients and their caregivers about their medicines to maximize adherence and reduce the risk of medication misuse. USP General Chapter <1265> Written Prescription Drug Information – Guidelines provides guidance on prescription drug leaflet information format, content, and accessibility. Proposed revisions to this chapter include additional formatting information, principles for developing medication guides, health equity/accessibility considerations, and ways to incorporate emerging technologies. We invite you to review the proposed revisions and to provide comments here⤵️: https://ow.ly/sfE250T8YxC #Pharmaceuticals #USPScience

📢In the last few weeks, several health agencies from around the globe have published updated guidelines or extended deadlines related to nitrosamine impurities in pharmaceutical products. 1️⃣ Japan’s Ministry of Health, Labour and Welfare extended the deadline for manufacturers to implement mitigation strategies for nitrosamine impurities from Oct 31, 2024, to Aug 1, 2025 – timing that now aligns with the U.S. FDA’s deadline for industry to finalize confirmatory testing for Nitrosamine Drug Substance-Related Impurities (NDSRIs) in drug products and submit required changes to drug applications. 2️⃣ Health Canada | Santé Canada published an updated list of established acceptable intake (AI) limits for a handful of nitrosamines. 3️⃣ Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) published a highly anticipated guidance for industry stressing the importance of risk assessment as well as collaboration with ingredient suppliers. 4️⃣ The Brazilian Health Regulatory Agency (ANVISA) published a revision of its nitrosamines guideline to include the adoption of the Carcinogenic Potency Categorization Approach framework for AI limits as well as an acceptance of the enhanced Ames test as part of the safety strategy for industry in Brazil. Too many developments to keep up with? These regulatory agency updates are hot topics of discussion at USP’s Nitrosamines Exchange, the online knowledge-based community for all things Nitrosamines Impurities. Join the discussion! Not a member? It’s free to sign up; join today! ⤵️ https://ow.ly/fhXi50T2pI9