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

James T. Isaacs, Philip J. Almeter, Bradley S. Henderson, Aaron N. Hunter, Thomas L. Platt, Robert A. Lodder

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)915-927
Number of pages13
JournalApplied Spectroscopy
Issue number8
StatePublished - Aug 2023

Bibliographical note

Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The project described was supported in part by NSF ACI-1053575 allocation number BIO170011 and the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant no. UL1TR001998.

Publisher Copyright:
© The Author(s) 2023.


  • NIR spectrometery
  • Near-infrared spectrometry
  • Raman spectrometry
  • sterile pharmaceuticals

ASJC Scopus subject areas

  • Instrumentation
  • Spectroscopy


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