1. Short title This Act may be cited as the Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 . 2. Urgent-use compounding for administration in hospitals or other clinical settings Section 503A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353a(a) ) is amended— (1) in paragraph (1), by striking or at the end; (2) in paragraph (2)(B)(ii)(II), by striking the period at the end and inserting ; or ; and (3) by adding at the end the following new paragraph: (3) notwithstanding the requirement in the matter preceding paragraph (1) that the drug product is compounded for an identified individual patient based on a valid prescription order or notation described in such matter, is by a licensed pharmacist or licensed physician and the compounded drug product is compounded for distribution in limited quantities to a licensed prescriber for urgent administration to a patient in a hospital or other clinical setting, provided that all of the following are met: (A) The licensed prescriber certifies by notation on the order to the compounding pharmacist or physician that the licensed prescriber has made reasonable attempts to obtain, and has not been able to obtain, to address the urgent medical need— (i) a drug product that is approved or authorized by the Food and Drug Administration with the same active ingredient and the same route of administration; or (ii) a drug product that is compounded by an outsourcing facility in accordance with section 503B with the same active ingredient and the same route of administration. (B) The compounded drug product is labeled with a beyond-use-date in accordance with applicable United States Pharmacopeia standards. (C) The licensed pharmacist or licensed physician marks the packaging of the compounded drug product with text— (i) indicating that the drug product is provided to the hospital or other clinical setting only for urgent administration to a patient