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In none of those instances has the board demonstrated how these excessive regulations make patients safer. A threat to patient access The proposed regulations, which allow for very limited exceptions, threaten to end patient access to all 47 Category 1 Sterile Compounds despite the fact that they are federally allowed under the FDAs interim policy

doi: 10.3389/fphar.2025.1601712 Received 28 March 2025 Accepted 27 May 2025 Published 23 June 2025 Volume 16 - 2025 Edited by Ashish Mehta, Garvan Institute of Medical Research, Australia Reviewed by Ankul Singh S, ACS Medical College and Hospital, India Prabhash Nath Tripathi, University of Arkansas for Medical Sciences, United States Updates Copyright 2025 Aktary, Jeong, Oh, Shin, Sung, Rahman, Ramos Santiago, Choi, Song, Nurkolis, Ribeiro, Park and Kim

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For others, it may take a few weeks of consistent use