; (B) what information manufacturers of critical essential medicines should send to the Secretary; and (C) what communications from the manufacturer the Secretary would request with respect to increases in demand following such notifications. (2) Consultation In developing such guidance, the Secretary shall consult with relevant stakeholders, including manufacturers of critical essential medicines and local, State, or Federal public health officials. (3) Timing The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue— (A) draft guidance under paragraph (1) not later than 120 days after the date of the enactment of this Act; and (B) final guidance under such paragraph not later than 180 days after the date of the enactment of this Act. E Protecting Americans from unsafe drugs 541. 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) ), as amended by section 3503(a)(4)(C) of division FF of Public Law 117–328 , 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 .