. 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 in their public health responsibilities.
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 toAs the so-called “inactive" ingredients in medicines, excipients are often mistaken as being free from potential harm. But the evidence suggests otherwise.
Excipients are critical materials and serve a broad variety of functions. They serve as fillers, help the body to absorb the medicine, and add flavor or color to drugs. In fact, some are often found in food products, such as lactose, peanut oil, and starch. In the United States, excipients are approved by the FDA as part of the review process for the finished medicine; they are considered by the regulatory agency as generally recognized as safe or “GRAS.
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