Julie Dohm, PhD, JD, Of Counsel at Covington & Burling, discusses some of the risks associated with drug compounding, including uncertain ingredients, quality of how the compounds are made, labeling of drug, and untested formulas.
Julie Dohm focuses on regulatory matters for pharmaceutical and biotechnology companies, and between 2016 and 2019, she served as the lead on compounding for the U.S. Food and Drug Administration (FDA).
As Julie explains in this video, 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 medications. Unnecessary use of compounded drugs can needlessly expose patients to health risks. These risks are discussed in the video.
FDA encourages health care professionals to report adverse events and product quality defects associated with compounded drugs to FDA’s MedWatch Adverse Event Reporting program: Complete and submit the report online at www.fda.gov/medwatch/report.htm