Philip Schneider, MS FASHP FFIP
As a pharmacist, my priority is helping patients benefit from medicines, and protect them from harm caused by medicines intended to help them. This week we saw an example of why the oversight of the U.S. Food and Drug Administration (FDA) is so important in this regard.
FDA-approved medicines are manufactured in facilities that must follow strict current Good Manufacturing Practices (cGMP), undergo routine inspections, and perform extensive testing to ensure purity, potency, and consistency. Unlike FDA-approved drugs, compounded medicines do not undergo the same level of review or manufacturing oversight.
The recent analysis reported in Reuters found undisclosed impurities in multiple samples of compounded versions of a popular GLP-1 weight-loss drug, raising potential safety concerns. Compounding has an important role for individualized patient needs, but mass-produced compounded copies of FDA-approved drugs can expose patients to unnecessary risk. This report highlights why it is critical the FDA follow through on Commissioner’s recent commitment to police large-scale compounding and protect patients.