There are many more ingredients in every pill you take than what is listed on the bottle label. These other ingredients, which are combined with the therapeutic one, are often sourced from around the world before landing in your medicine cabinet and are not always benign.
Earlier this year, the U.S. Congress passed the Coronavirus Aid, Relief and Economic Security Act, which requires manufacturers to report real or potential drug shortages to the FDA. Manufacturers are now required to report disruptions in the manufacturing of an active pharmaceutical ingredient – the part of the medicine that produces the intended therapeutic benefit.
But the CARES Act doesn’t include excipients – the “inactive” ingredients that make up the bulk of a final medicine. It also doesn’t include the materials needed to package and distribute medical products, such as vials and other containers, packaging, and labels. While the CARES Act improves the flow of information and may signal potential drug shortages, it is intended to support regulators (like the FDA) in their public health responsibilities. It does not increase transparency to consumers of medicines.
As a trained pharmacist and researcher interested in uncovering risks to medicine quality, I believe patients and clinicians would benefit from having more information about all the ingredients in medicine. But for this to happen additional measures are needed to increase transparency for all components of a medicine, including excipients.
Product labeling for ‘inactive’ ingredients
As the so-called “inactive” ingredients in medicines, excipients are often mistaken as being