Almeter PJ, Isaacs JT, Hunter AN, Henderson BS, Platt T, Mitchell BJ, Do D, Brainard AB, Brown JE, Stone RM, Nguyen BH, Warren MF, Bhaktawara SA, Bossle MN, Long LM, Zapata SP, Larkin CR, Lyman TA, Larkin SA, Labuhn JA, Reynolds JW, Schuler EE, Naseman RW, Johnson GL, and Lodder RA
Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities., Competing Interests: Conflict of InterestThe authors declare no competing interests., (© The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022.)