FDA Actions

The FDA is launching a program to improve the safety of imported drugs to the United States. The pilot program would allow manufacturers of drugs outside United States to apply for 1 of 100 certifications, which would require that companies have a secure supply chain for their product. Criteria would include holding an FDA-approved drug application, guaranteeing that active pharmaceutical ingredients would be imported only to make FDA-approved drugs, complying with Good Manufacturing Practices, and guaranteeing that their drug products use a secure supply chain. This program is in response to concerns about manufacturing processes outside the United States and the embargoing of several foreign manufactured drugs in the last year.