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doi: 10.3389/fimmu.2025.1702860 Received 10 September 2025 Accepted 20 October 2025 Published 30 October 2025 Volume 16 - 2025 Edited by Jorge B
doi: 10.3389/fmed.2021.661076 47 HarrisonLEGiardinaCHightowerLEAndersonCPerdrizetGA
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The FDA's 2022 guidance on bulk drug substances explicitly named BPC-157 as a compound that does not meet the criteria for inclusion in compounded drug preparations under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act
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