Did you know? In the early days of U.S. history, widespread inconsistency in medicine preparation led to problems in their quality and effectiveness and put patients at risk. This urgent problem led to the creation of the United States Pharmacopeial Convention in 1820, when a small group of physicians came together to address the crisis by establishing the first U.S. standards for medicine quality.
Today, our 10,000+ documentary and reference standards are used in the United States and more than 150 countries, helping improve people’s health and supporting a resilient medicine supply for all. 🌍💊
Watch the video to learn more about our journey and impact! 📽️
watch video on watch page
2 - 0
🚨 Nitrosamine impurities are in the news again, with the announcement of a recall of nearly 1.5 million bottles of an ADHD medication, atomoxetine capsules, due to the presence of N-nitroso atomoxetine at levels that exceed the U.S. FDA’s recommended acceptable intake limits. Nitrosamines are a type of impurity in pharmaceuticals that can potentially increase cancer risk with long-term exposure.
Nitrosamines, including nitrosamine drug substance-related impurities (NDSRIs), can be formed in a variety of ways, from raw ingredients to manufacturing processes, including during packaging and storage. The pharmaceutical industry and regulators are working to limit the presence of nitrosamines in drugs to acceptable levels to ensure a safe supply of medicines and to help prevent the need for recalls, which take place when unacceptable levels of the impurities are detected in products.
The atomoxetine recall comes less than six months ahead of the August 1, 2025 FDA-requested deadline to finalize confirmatory testing for NDSRIs in drug products and submit required changes to drug applications.
USP is helping the industry prepare for the deadline with resources and solutions including quality standards and reference materials, validated test methods, and the Nitrosamines Exchange, the online community platform where members are actively engaged in discussion and knowledge-sharing.
Stay informed about the latest developments in controlling nitrosamine impurities in pharmaceuticals:
watch video on watch page
1 - 0
What is the USP Medicine Supply Map and how does it help ensure access to quality medicines and support a more reliable global supply chain? watch video on watch page
4 - 0
What are excipients and why are they important to ensuring the quality of medicines?
Click here to learn more: ow.ly/hjIA50TuvnF
watch video on watch page
0 - 0
Have you read our inaugural Drug Shortages report yet?
Using our Medicine Supply Map (MSM), a tool that uses artificial intelligence and predictive analytics to identify, characterize, and predict risk in the complex medicine supply chain, this report sheds light on four factors that singularly, or in combination, can leave a drug more vulnerable to shortage.
Take a look at our virtual briefing of the report here:
watch video on watch page
2 - 0
Did you know that up to 90 percent of a drug consists of excipients – inactive substances that function as binders, disintegrants, solubilizers, coatings, preservatives, colors, flavorings, drug release and delivery agents? Inferior quality excipients can lead to poor drug dissolution and bioavailability and can trigger toxic contaminations like diethylene glycol (DEG), which can have fatal consequences. watch video on watch page
1 - 0
PQM+ staff conducted an assessment at a local pharmaceutical manufacturer, YSI Pharmaceuticals in hashtagBurma to assess YSI's good manufacturing practices (GMP) compliance, an essential credential for ensuring strong health systems. This program receives support from USAID (@USAID Video) through the President's Malaria Initiative (PMI). Check out this video of the process here! watch video on watch page
0 - 0
“Standards have been shown to increase regulatory confidence, reduce the cost of developing medicines, which unlocks resources for innovation, and increases the supply of treatments available for patients.”
In a recent interview with @PharmacyTimesTV Fouad Atouf, USP Global Biologics SVP discussed the vital role of quality standards in the evolution of biosimilars and biologics landscape.
The field of biologics is vast and growing, with tremendous potential to improve patients’ lives and public health. Novel biologics and biosimilars – or biologics highly similar to an existing biologic already approved – also hold great promise to help increase availability of quality biologic medicines for conditions ranging from diabetes to cancer.
watch video on watch page
0 - 0
As the market for dietary supplements continues to grow due to increasing consumer demand, participating in USP's Dietary Supplement Verification Program can give manufacturers a competitive advantage by demonstrating their commitment to creating and distributing quality products.Learn more about our Dietary Supplement Verification Program here: ow.ly/foxV50Rhg4L watch video on watch page
1 - 0
Meet Naiffer Romero, a Principal Scientist at USP. He serves as the community manager for the Nitrosamines Exchange, a knowledge-based online community built by USP where 4,500+ members around the world are dedicating their time and individual expertise to information-sharing that is helping advance the science and understanding of nitrosamines.Membership is free. Join us in the discussion! ➡ nitrosamines.usp.org/ watch video on watch page
1 - 0
USP works to build trust where it matters most: in the world's medicines, dietary supplements and foods. Through rigorous science and public quality standards we set, we help protect patient safety and improve the health of people around the world.
USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines since 1820. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected.
Learn more: www.usp.org