This bill prohibits, with some exceptions, the Food and Drug Administration (FDA) from providing notification in advance of a planned inspection of an establishment located outside of the United States that is engaged in drug manufacturing, processing, packing, or holding.
Specifically, the FDA may not provide such an establishment advance notification of a planned inspection unless (1) advance notification is required by the laws of the country where the establishment is located; (2) providing advance notification is needed to protect the public health; or (3) the inspection in question is a preapproval, prelicensure, or for-cause inspection. If the FDA must provide advance notification, it must minimize the time between the notification and the inspection.
If an establishment is located in a country that, on or after the date this bill is enacted, enacts a law requiring advance notification of inspections, the drug manufacturer must agree to waive the right to enforce the requirement, to the extent expressly permitted by the law.
