Spectrometric Assessment of Generic and Brand Drug Quality for a Sentinel Screening Network

The U.S. Food and Drug Administration (FDA) is a worldwide leader among analogous regulatory organizations in other countries. The FDA uses current good manufacturing practices to regulate the processes that produce drugs. Nevertheless, investigative journalists have pointed out problems in the drug supply, and pharmacies are not required to test the drugs they receive. The University of Kentucky Drug Quality Study does perform screening on the sterile injectable drugs that it receives and regularly reports new findings to FDA, practitioners, and the public. A Sentinel Screening Network of academic health systems could provide independent data on drug quality to FDA not available through manufacturers.

Automated summary

The U.S. FDA is a global leader in drug regulation and applies good manufacturing practices. However, investigative journalists have identified issues in the drug supply, as pharmacies are not required to test received drugs. The University of Kentucky Drug Quality Study performs screening on injectable drugs and shares findings with FDA, practitioners, and the public. The establishment of a Sentinel Screening Network could provide additional independent data on drug quality to the FDA.