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doi: 10.1016/j.biomaterials.2025.123139 51 BaiWShinJFuRKandelaILuDNiXet al

Understanding the 503A Bulks List Section 503A of the Federal Food, Drug, and Cosmetic Act sets the conditions that must be met for a compounded drug product to be exempt from three key federal requirements: current good manufacturing practice standards, labeling with adequate directions for use, and approval under a new drug application