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.

大约 60 年前，美国食品和药物管理局 (FDA) 开始通过执行当前的良好生产规范来监测药品生产质量，与全球经济相关的力量发生了变化，使得监测质量的任务变得更加困难。Valisure、LLC 和肯塔基大学药物质量研究等团体通过最终产品测试和筛选监测当前流通的美国药物供应质量的替代策略已经产生了一些令人担忧的发现。鉴于非监管机构识别药品质量缺陷的成功方法，并考虑到不断变化的环境和制造业、FDA、大型采购集团面临的压力，