Opioid Crisis: USP’s Comments to the FDA
As government agencies consider solutions to the growing opioid crisis, the Food and Drug Administration (FDA) recently sought public comment about ways to best address this national emergency.
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.
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.
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 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.
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.
Dissolution, disintegration and drug release tests are important tools during the entire lifecycle of a drug product, from early development throughout its shelf life. USP’s Margareth Marques, Ph.D., provides answers to common questions and insight into standards and resources for these tests.