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Official blog of US Pharmacopeia (USP), sharing unique viewpoints on the public-health impact of worldwide efforts to promote the quality and integrity of medicines, food ingredients and dietary supplements. Writers include scientists, staff, volunteer experts and representatives of USP member organizations.
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USP Volunteers Develop Standard that Improves Test Critical to Cellular Transplant CareUSP Volunteers Develop Standard that Improves Test Critical to Cellular Transplant Care For patients needing a bone marrow or stem cell transplant, successful treatment often depends on finding a viable transplant sample with the right amount of hematopoietic stem cells (HSCs) to rebuild the patient’s immune system. Each year, more than 50,000 such transplants are performed around the world, according to the World Health Organization. Finding a well-matched donor with enough...
Why We Do It: A Volunteer’s Perspective on Setting USP Standards
Why We Do It: A Volunteer’s Perspective on Setting USP Standards January 1 was more than just the start of a new year for USP in 2018. It was the implementation date of two new standards designed to safeguard the global drug supply from potentially toxic impurities – mercury, cadmium, arsenic, and lead, for example. Known as General Chapters Elemental Impurities—Limits and Elemental Impurities—Procedures, these standards were the result of a thirteen-year effort,...
Our Legacy of Championing Access to Medicines
Our Legacy of Championing Access to Medicines Access to medicines is a complicated topic. It’s shaped by scientific factors, manufacturing processes, regulatory requirements (including expectations for quality), purchasing practices, health insurance coverage and benefits, healthcare practitioners and numerous other complex realities. What we have learned is that real progress happens when stakeholders work together to develop solutions. USP is using its capabilities to...
Medicine Quality Must Be Assured, Not Assumed
Medicine Quality Must Be Assured, Not Assumed When a problem puts millions of lives at risk, costs economies billions of dollars and undermines decades of hard-earned health progress, it deserves prompt and strategic attention. I’m describing the consequences of poor-quality medicines – a worldwide problem that deserves worldwide attention. Yet in many public health policy discussions, it receives little, if any, consideration. Now is the time for us to prioritize the issue of...
The Role of Standards in Personalized Medicine
The Role of Standards in Personalized Medicine As personalized therapies have become a reality rather than a distant promise, the tools needed to ensure the quality of these medicines grow increasingly important. Regulatory guidances for personalized medicines are frequently a “work in progress,” evolving over time as the body of knowledge grows for ensuring that these therapies are safe and beneficial. Regulatory considerations for personalized medicines are often related to...
Digital Therapeutics: How to Ensure Quality in an Emerging Field
Digital Therapeutics: How to Ensure Quality in an Emerging Field Imagine using software on your phone or tablet to treat health conditions that, until now, could only be treated with medications. Now stop imagining, because for some conditions, such as attention deficit disorder and substance dependency, it is already a reality. I’m talking about the new field of digital therapeutics (DTx). The US Food and Drug Administration (FDA) has recently approved several of these digital...
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