How does FDA oversee domestic and foreign drug manufacturing?

All drugs approved in the United States, regardless of where they are made, must be in compliance with the Federal Food, Drug, and Cosmetic Act, which requires that drugs meet manufacturing standards to assure quality and product label requirements. FDA oversees drug manufacturing in several ways.

• First, domestic and foreign drug manufacturing plants are routinely inspected for compliance with applicable regulations, including the Current Good Manufacturing Practices.
• Second, FDA samples and tests drugs from retail stores, distribution warehouses, and manufacturing sites. FDA also evaluates complaints from consumers, doctors and nurses, and other reports of drug defects. This information helps FDA identify the need for enforcement action, surveillance activity, educational outreach, new guidance documents, and new regulations.

Some drugs approved in our nation are either fully manufactured overseas, or made in the United States but have some foreign ingredients. The amount of foreign-made drug products in the United States is rapidly increasing. In 2009, imports regulated by FDA doubled since 2004.

Under FDA’s Globalization Initiative, the agency addresses the challenge of making sure imported drugs, as well as other products, are as safe and effective as products made in the United States.  For example, the agency enters into arrangements with foreign counterpart regulatory authorities to share information about products, which improves FDA’s ability to protect U.S. consumers from unsafe drugs manufactured outside the United States.  FDA has also posted staff in certain overseas regions (including China, India, Europe, and Latin America) to expand oversight of imported medical products.

FDA does not oversee the manufacturing of drugs that are imported illegally into the United States, such as those that consumers purchase from Canada or other sources on the Internet, and their quality cannot be assured by FDA.