; (2) in paragraph (2)(A) (as so redesignated), by striking and that is subject to section 503(b)(1) and inserting , including a drug that is not subject to section 503(b)(1) ; and (3) by inserting before paragraph (2) (as so redesignated) the following: (1) the term critical essential medicine means a drug that— (A) is— (i) life-supporting; (ii) life-sustaining; or (iii) intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 319 of the Public Health Service Act; and (B) is not a radio pharmaceutical drug product or any other product as designated by the Secretary; . (c) Regulations Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to implement the amendments made by subsections (a) and (b). (d) Guidance (1) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue guidance on the requirements for notifications required to be submitted under section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ), as amended by subsections (a) and (b), with respect to increased demand for critical essential medicines (as defined in such section 506C). Such guidance shall specifically address— (A) the ways in which manufacturers of critical essential medicines can improve demand predictability; (B) what information manufacturers of critical essential medicines should send to the Secretary