If you ever wonder why we have such strict rules when it comes to pharmaceuticals in the U.S., this article shows, quite clearly, the reasons for those rules. There were more than 64 deaths and more than 680 people developing meningitis and other infections because a small group of people didn't follow the rules.
From the Sulfanilamide incident in the US to the Thalidamide birth defects worldwide to the Tylenol Murders in Chicago, the rules surrounding the manufacture, preparation, and sale of drugs in the US were created from and shaped by death and tragedy. Our laws have been mostly reactive, and they are only strict because it has been proven time and again that they need to be. Shortcuts and adulteration costs lives. The FDA and cGMPs (and Title 21 of the Code of Federal Regulations) exist to save lives and protect the consumer, despite the organization being an apparently easy punching bag for pundits and politicians.
When the rules seem onerous or inconvenient, remember why they are there.