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

Author:

Isaacs James T.1,Almeter Philip J.12,Henderson Bradley S.1,Hunter Aaron N.1,Platt Thomas L.1,Lodder Robert A.3ORCID

Affiliation:

1. Department of Pharmacy Services, University of Kentucky, Lexington, Kentucky, USA

2. Pharmacy Practice and Sciences, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA

3. Department of Pharmaceutical Sciences, University of Kentucky, Lexington, Kentucky, USA

Abstract

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.

Funder

Center for Scientific Review

Publisher

SAGE Publications

Subject

Spectroscopy,Instrumentation

Reference18 articles.

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3. U.S. Government Printing Office. “Kefauver–Harris Amendment to the Federal Food, Drug, and Cosmetic Act”. Pub L. No. 87–781, 1962. https://www.govinfo.gov/content/pkg/STATUTE-76/pdf/STATUTE-76-Pg780.pdf [accessed Jan 3 2023].

4. U.S. National Research Council. “Drug Efficacy Study: Final Report to the Commissioner of Food and Drugs: Food and Drug Administration”. Washington, DC: The National Academies Press, 1969. https://nap.nationalacademies.org/download/24615# [accessed Jan 3 2023].

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