Mitigating drug shortages through improved reporting

Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amended— (1) in the section heading, by inserting OR SURGE IN DEMAND FOR after PRODUCTION OF; (2) in subsection (a), in the matter following paragraph (2)— (A) by striking or an interruption of the manufacture of the drug and inserting, an interruption of the manufacture of the drug, or a surge in demand for the drug; (B) by striking such discontinuance or interruption and inserting such discontinuance, interruption, or surge in demand; (C) by striking the discontinuation or interruption and inserting the discontinuation, interruption, or surge in demand; (D) by striking such discontinuation or interruption, the source and inserting such discontinuation, interruption, or surge in demand, the source; and (E) by striking such discontinuation or interruption; the expected duration of the interruption; and inserting such discontinuation, interruption, or surge in demand; the expected duration of the interruption or surge in demand; (3) in subsection (b), by striking paragraphs (1) and (2) and inserting the following: (1) in the case of a notice of a discontinuance or interruption in the manufacture of a drug— (A) at least 6 months prior to the date of the discontinuance or interruption; or (B) if compliance with subparagraph (A) is not possible, as soon as practicable; or (2) in the case of a notice of a surge in demand for a drug, as soon as practicable.; (4) in subsection (c)— (A) by striking discontinuance or interruption and inserting discontinuance, interruption, or surge in demand; and (B) by inserting and outsourcing facilities (as defined in section 503B(d)) after patient organizations; and (5) in subsection (h)— (A) in paragraph (1), by striking and that is subject to section 503(b)(1) and inserting or the active pharmaceutical ingredient of such a drug; (B) by amending paragraph (2) to read as follows: (2) the term drug shortage or shortage, with respect to a drug, means a period of time with the demand or projected demand for the drug within the United States exceeds the supply of the drug, taking into consideration— (A) how the drug is prepared or dispensed, including the route of administration and dosage form; and (B) information reported by manufacturers, health care professionals, and patients;. (C) in paragraph (3)(B), by striking the period at the end and inserting; and; and (D) by adding at the end the following: (4) the term surge means an increase in demand or projected demand for a drug that the manufacturer likely will be unable to meet without meaningful shortfall or delay..