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  • September 24, 2019

SILVER SPRING, MD—The FDA proposed an amendment to its 503A Bulks List regulations to add five substances to the list of bulk drug substances (APIs) that can be used in compounding although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. The proposed amendment also identifies 26 bulk drug substances that the FDA has considered and proposes not to include on the list.