I 118th CONGRESS 1st Session H. R. 2500 IN THE HOUSE OF REPRESENTATIVES April 6, 2023 Mr. Kim of New Jersey introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to expand certain authorities with respect to the recall of controlled substances to apply with respect to all drugs, and for other purposes.

1. Short title This Act may be cited as the Protecting Americans from Unsafe Drugs Act of 2023 . 2. Notification, nondistribution, and recall of drugs (a) Order To cease distribution and recall Section 569D of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8d ) is amended— (1) in the section heading, by striking controlled substances and inserting drugs ; (2) by striking controlled substance each place such term appears and inserting drug ; (3) in subsection (b)— (A) by striking controlled substances and inserting drugs ; and (B) by inserting of subsection (a) after an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) ; and (4) in subsection (c), by striking or an official senior to such Director and inserting or the Director of the Center for Biologics Evaluation and Research (or an official senior to either such Director) . (b) Imports and exports Section 801(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381(a) ) is amended by striking is a controlled substance subject to an order under section 569D and inserting is a drug subject to an order under section 569D .