As personalized therapies have become a reality rather than a distant promise, the tools needed to ensure the quality of these medicines grow increasingly important. Regulatory guidances for personalized medicines are frequently a “work in progress,” evolving over time as the body of knowledge grows for ensuring that these therapies are safe and beneficial.
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. Then, in the mid-1800s, analytical chemistry evolved to enable quality testing. Fundamentally, medicine quality is concerned with the identity, strength, purity, and performance of a product or ingredient (i.e., What is it? How much of it is there? Is there anything else present?
When is an airline a critical part of the healthcare system? When countries—such as Ethiopia—must import life-saving medicines.
If you ask people about what it takes to ensure medicines quality, most answers focus on how a medicine is manufactured. But there’s more to the story. The conditions under which medicines are transported and stored also have a critical role in medicines quality. This role is all the more urgent when the lives of mothers and children are at stake.
This week Congress will hold an important and timely hearing on compounded drugs. The hearing brings stakeholders together to reflect on a law enacted nearly five years ago in response to serious public health incidents. In 2012, a nationwide fungal meningitis outbreak originating from contaminated injectable compounded sterile drugs sickened over 750 individuals and resulted in the deaths of more than 70.
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.