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.
With significant innovations in pharmaceuticals, including biologic drugs and treatments for rare diseases, the need for new and better functioning excipients to improve drug delivery is growing.
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.
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.
Regardless of whether it’s prescription or over-the-counter, the ingredients on a drug product label typically include one, maybe two, active pharmaceutical ingredients (APIs). The rest of the list is comprised of “inactive” ingredients (excipients) which in reality are far from inactive. Variability may be acceptable for products such as printer ink and paintballs, but not pharmaceuticals, making quality standards for excipients critical to ensuring consistent drug quality.
Pharmacopeial Forum (PF) is the vehicle through which USP publishes proposed revisions to USP–NF standards for public review and comment. Learn about PF and how you can use it to help shape standards for drugs, excipients and dietary supplements.
Today, approximately 80% of all active pharmaceutical ingredients in medicines sold in the U.S. are manufactured in another part of the world. While manufacturers have to ensure the quality and consistency of ingredients that go into final pharmaceutical products, they must also employ measures for the proper control of unwanted impurities in drugs and drug ingredients.
USP recruits expert volunteers during a call for candidates for its 2015-2020 cycle.