For a hundred years, federal law has required that all drugs adhere to public quality standards—part of ensuring safety and protecting the public’s health. Language that would exempt biologics, including biosimilars, from adhering to the same public quality standards as other prescription medicines was recently added to the FDA and NIH Workforce Authorities Modernization Act. Learn about the potential impact this biologics quality exemption may have on competition, product development, and the public's confidence in biologics and biosimilars.
Today, many critical, life-saving medicines go through a complex global supply chain before ever reaching the patient. USP’s public standards play important roles throughout that supply chain. Learn more.
On this World Malaria Day, the world is calling for an end to malaria. We must increase efforts to ensure that antimalarials used to treat malaria are safe, effective and of good-quality. Here are some ways we can close the treatment gap and provide the millions of people newly infected with malaria each year with reliable, quality-assured medicines.
Learn about USP's involvement in the APEC Life Sciences Innovation Forum and how this group is improving access to quality medical products by helping Asian-Pacific economies prevent, detect and respond to spurious, substandard, falsified, falsely-labelled and counterfeit products in their supply chains.
Find out answers to important questions about your medications during a special live Twitter Chat “Medication Safety 101: Usage, Storage, and Disposal” on March 23. Hosted by the Alliance for Aging Research, in partnership with NCPIE, the Acetaminophen Awareness Coalition, the American Association of Poison Control Centers, and the CHPA Educational Foundation, this online discussion aims to answer common patient questions on how to safely choose, take, store, and dispose of OTC medications.
Plastic packaging systems play an important role in protecting the drugs we use. However, a drug’s packaging must be compatible with the product and not compromise its stability, efficacy or safety. USP’s Desmond Hunt, Ph.D., provides insight into plastic packaging systems for drugs and how USP standards can support quality in this field.
Learn about and view the new suite of physical and written standards that USP is developing to help biologics manufacturers develop and analyze therapeutic proteins. New general chapters address analytical procedures for monoclonal antibodies, oligosaccharides, and protein determination.
Learn what the letters “USP” mean on medicine labels, the origin behind them, and how they are related to U.S. laws that aim to protect medicine and dietary supplement quality.
Patrick Lukulay, USP’s VP of GHIP–Africa, discusses plans to leverage his new post in Accra, Ghana to advance pharmaceutical quality in Africa. Countering fallacies in drug quality through advocacy and working to help build an enabling environment that can sustain systems for effective regulation of medical products, he says, are needed for this to happen.