S. 3509 · 117th Congress
Creating Efficiency in Foreign Facility Inspections Act
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
BraunSponsor2 cosponsors · 2 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Introduced in Senate · Jan 13, 2022
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Creating Efficiency in Foreign Facility Inspections Act
Latest action (Jan 13, 2022): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Jan 13, 2022
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.