; (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; (B) is not a radio pharmaceutical drug product or any other product as designated by the Secretary; and (C) is not a biological product (as defined in section 351(i) of the Public Health Service Act), unless otherwise provided by the Secretary in the regulations promulgated under subsection (i); . 3. Reporting on supply chains Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j)(3)(A) ) is amended— (1) by striking annually to the Secretary in the first sentence and inserting to the Secretary, once during the month of March each year and once during the month of September each year, ; (2) by inserting , and the legal names of, and any additional information the Secretary may require, regarding suppliers of active pharmaceutical ingredients and intermediate and in-process materials such person used for the manufacture, preparation, propagation, compounding, or processing of such drug, and the amount of such drug manufactured, prepared, propagated, compounded, or processed using each such active pharmaceutical ingredient or intermediate or in-process material sourced from each such supplier before the period at the end of the first sentence; and (3) by inserting after the first sentence the following: In addition to the reporting required under the preceding sentence, each person who registers with the Secretary under this section with regard to a drug may voluntarily report on the information described in the preceding sentence, at such other times as the Secretary may specify. .