Improved Transparency of Foreign Drug Manufacturing Act of 2022
This bill modifies requirements for certain foreign establishments that manufacture drugs (including active pharmaceutical ingredients) to register with the Food and Drug Administration (FDA).
Under this bill, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.
A non-U.S. manufacturing establishment must also file with the FDA a list of drugs manufactured by the establishment. For each drug on the list, the establishment must (1) identify every other known establishment where additional manufacturing is performed, and (2) notify each foreign establishment involved of the listing of the drug and the obligation to register with the FDA.
The bill also requires each registered non-U.S. manufacturing establishment to report every three months to the FDA a list of each drug it manufactures for commercial distribution, where currently this report is required once a year.