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Creating Efficiency in Foreign Facility Inspections Act

USA117th CongressS-3509| Senate 
| Updated: 1/13/2022
Mike Braun

Mike Braun

Republican Senator

Indiana

Cosponsors (2)
Joni Ernst (Republican)Josh Hawley (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jan 13, 2022
Introduced in Senate
Jan 13, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 13, 2022
    Introduced in Senate


  • January 13, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Creating Efficiency in Foreign Facility Inspections Act

USA117th CongressS-3509| Senate 
| Updated: 1/13/2022
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.
View Full Text

Suggested Questions

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Timeline
Jan 13, 2022
Introduced in Senate
Jan 13, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 13, 2022
    Introduced in Senate


  • January 13, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mike Braun

Mike Braun

Republican Senator

Indiana

Cosponsors (2)
Joni Ernst (Republican)Josh Hawley (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted