Julie Dohm, Of Counsel at Covington & Burling based in Silver Spring, Maryland, discusses some of the key differences between FDA-approved drugs versus compounded medications. Between 2016 and 2019, Julie served as the lead on compounding for the U.S. Food and Drug Administration (FDA).
Although compounded drugs can serve an important medical need for patients, they do not have the same safety, quality, and effectiveness assurances as FDA approved drugs. Unnecessary use of compounded drugs can needlessly expose patients to potentially serious health risks. For example, with FDA approved medications, there is consistency across all products.
Because compounded drugs are not FDA-approved, the FDA does not verify their safety, effectiveness, or quality before they are marketed. In addition, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient. This can lead to serious patient injury and death.
For more information drug compounding including FDA resources, visit the CheckRare drug compounding page here.