Section 1 Short title
This Act may be cited as the “Protecting Americans from Unsafe Drugs Act of 2023”.
Protecting Americans from Unsafe Drugs Act of 2023
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.
Sec. 2 Notification, nondistribution, and recall of drugs
Order To cease distribution and recall— Section 569D of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8d) is amended—
in the section heading, by striking “controlled substances” and inserting “drugs”;
by striking “controlled substance” each place such term appears and inserting “drug”;
in subsection (b)—
by striking “controlled substances” and inserting “drugs”; and
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
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)”.
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”.