In the Food and Drug Administration Modernization Act of 1997, Congress specifically exempted drugs compounded for identified individual patients from the same requirements governing manufactured drugs.
And the impacts should be greatest of all at organizations such as the Food and Drug Administration that act as gatekeepers, or brakes, on innovative products and technologies because they must grant premarketing approvals.
There was an opportunity in the Senate and House bills on FDA reform (the Food and Drug Administration Safety Act of 2007) to do something about this and I as a reformer am disappointed in the failure of both bills to strengthen post-market surveillance.
The Family Smoking Prevention and Tobacco Control Act of October, 2009, gave the Food and Drug Administration (FDA) power to regulate smokeless tobacco products.