Registration of Certain Foreign Establishments Act

Bill: 117-s-3449
Sponsor: full_name: Sen. Peters, Gary C. [D-MI]
Introduced: 2022-01-10
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Health technology, devices, supplies

Licensing and registrations

Manufacturing
Latest action: action_date: 2022-01-10
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2022-01-10
action_desc: Introduced in Senate
text: <p><strong>Registration of Certain Foreign Establishments Act</strong></p> <p>This bill expands statutory provisions that require foreign manufacturers of drugs or medical devices for the U.S. market to register with the Food and Drug Administration.</p> <p>Specifically, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug or medical device to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug or medical device in question undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.</p>

tv_txt: II 117th CONGRESS 2d Session S. 3449 IN THE SENATE OF THE UNITED STATES January 10, 2022 Mr. Peters (for himself and Ms. Collins ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device to register with the Food and Drug Administration regardless of whether the drug or device undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported into the United States.

1. Short title This Act may be cited as the Registration of Certain Foreign Establishments Act . 2. Registration of certain foreign establishments (a) Registration of certain foreign establishments Section 510(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(i) ) is amended by adding at the end the following: (5) The requirements of paragraphs (1) and (2) shall apply regardless of whether the drug or device undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported or offered for import into the United States. . (b) Updating regulations Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall update regulations, as appropriate, to implement the amendment made by subsection (a).