1. Short title This Act may be cited as the Drug Shortages Prevention and Quality Improvement Act . 2. Lengthen expiration dates to mitigate critical drug shortages (a) In general The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506C–1 ( 21 U.S.C. 356c–1 ) the following: 506C–2. Extended expiration dates for life-saving drugs (a) In general A manufacturer of a life-saving drug shall— (1) submit to the Secretary data and information as required by subsection (b)(1); (2) conduct and submit the results, data, and information of any studies required under subsection (b)(2); and (3) make any labeling change described in subsection (c) by the date specified by the Secretary pursuant to such subsection. (b) Notification (1) In general The Secretary may issue an order requiring the manufacturer of any life-saving drug to submit, in such manner as the Secretary may prescribe, data and information from any stage of development of the drug that are adequate to assess the stability of the drug to determine the longest supported expiration date. (2) Unavailable or insufficient data and information If the data and information required pursuant to an order issued under paragraph (1) are not available or are insufficient, the Secretary may require the manufacturer of the drug to— (A) conduct studies adequate to provide the data and information in accordance with section 211.166 of title 21, Code of Federal Regulations (or any successor regulations)