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. USP was pleased to provide our perspective about how public standards might help support the agency’s efforts, and to report on our recent discussions with stakeholders and the standards being considered by USP’s Healthcare Quality Expert Committee.  


Compendium, compendia, compendial: Clearing up the mystery of these terms

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. But their meaning can be a bit of a mystery to people who work outside of the pharmaceutical industry and regulatory bodies.


Pharmaceuticals, printers and paintballs: when variability in excipient quality is and isn’t acceptable

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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.