117 S3509 IS: Creating Efficiency in Foreign Facility Inspections Act U.S. Senate 2022-01-13 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II117th CONGRESS2d SessionS. 3509IN THE SENATE OF THE UNITED STATESJanuary 13 (legislative day, January 10), 2022Mr. Braun (for himself and Ms. Ernst) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo strengthen the authority of the Food and Drug Administration with respect to foreign drug facility inspections.

1.

Short title

This Act may be cited as the Creating Efficiency in Foreign Facility Inspections Act.

2.

Strengthening foreign drug facility inspections

Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the following:(i)(1)When the Secretary, and officers or employees duly designated by the Secretary, conduct inspections under this section of establishments engaged in the manufacturing, processing, packing, or holding of drugs that are located outside of the United States, the Secretary shall not notify the owner or operator of such establishment of the planned inspection before the inspection occurs unless—(A)notification to the establishment owner or operator in advance of an inspection is mandated under the laws of the country where the establishment is located, in which case, the Secretary shall provide not more than the minimum advanced notice so mandated; or(B)the Secretary determines that notification to the establishment owner or operator in advance of an inspection is needed to protect the public health.(2)(A)With respect to all inspections described in paragraph (1), the Secretary shall attempt to minimize the time between advance notification to an establishment owner or operator and the conduct of a surveillance inspection.(B)If the Secretary determines that notification to an owner or operator of a foreign establishment of an inspection in advance of a surveillance inspection pursuant to paragraph (1)(B) is needed, the Secretary shall provide such notification only as far in advance as is needed to protect the public health.(3)If an establishment is located in a country that, on or after the date of enactment of this subsection, enacts a law that prevents the Secretary from carrying out inspections as described in this subsection, the manufacturer shall agree to waive any right to enforce any advanced-notice requirement pursuant to such a law, to the extent expressly permitted under applicable local law. If the manufacturer does not agree to such a waiver, the manufacturer shall be deemed to have refused to permit entry or inspection in violation of section 301(f).(4)The requirement of paragraph (1) shall not apply to preapproval, prelicensure, or for-cause inspections..