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.
Consistent quality. Greater access. They’re what patients deserve and what USP strives to ensure across the globe through the development of public quality standards.
USP was founded nearly 200 years ago by eleven doctors who wanted to ensure that the nation had access to quality medicines. They put together the first pharmacopeia, a book of recipes for making tinctures, extracts, and other medicines.
In conversations about the role of quality standards in public health, you might come across the words “compendia” and “compendial.” At USP, terms like “compendial approaches,” “compendial standards,” and “compendial tools” are part of our everyday vocabulary.
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.
Stakeholders representing major gummy manufacturers, ingredient manufacturers, contract laboratories, and trade associations recently participated in a USP roundtable discussion on gummy dietary supplements. They shared their views on technical and quality challenges in manufacturing as well as scientific and public health considerations related to the future development of USP quality standards for gummy dietary supplements.
Discover convenient tools and helpful tips related to using USP Reference Standards in your work. USP Reference Standards are intended for quality control use in conducting assays and tests in USP’s documentary standards for drugs, dietary supplements, and foods.