Drug Shortage Compounding Patient Access Act of 2025

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 5316 Introduced in House (IH)] <DOC> 119th CONGRESS 1st Session H. R. 5316 To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain shortage and urgent-use compounded medications, and for other purposes. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES September 11, 2025 Mrs. Harshbarger (for herself and Mr. Carter of Georgia) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain shortage and urgent-use compounded medications, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Drug Shortage Compounding Patient Access Act of 2025''. SEC. 2. PHARMACY COMPOUNDING. (a) Compounding for Urgent Administration to Patients.--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: ``(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 drug product appeared on the drug shortage list in ef