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Creating Efficiency in Foreign Facility Inspections Act
12/15/2023, 4:07 PM
Summary of Bill S 1134
The main purpose of this bill is to streamline the process of inspecting foreign facilities by allowing the Food and Drug Administration (FDA) to rely on inspections conducted by foreign governments or recognized third-party organizations. This will help reduce the burden on the FDA and allow them to focus their resources on higher-risk facilities.
Additionally, the bill requires the FDA to prioritize inspections of facilities that have a history of non-compliance with US regulations or that produce high-risk products. It also mandates that the FDA develop a risk-based inspection model to determine the frequency and intensity of inspections for different types of facilities. Overall, the Creating Efficiency in Foreign Facility Inspections Act aims to improve the safety and quality of imported food and drugs by making the inspection process more efficient and targeted. It has received bipartisan support in Congress and is currently being considered by the Senate Committee on Health, Education, Labor, and Pensions.
Congressional Summary of S 1134
Creating Efficiency in Foreign Facility Inspections Act
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.
