The Food and Drug Administration (FDA) has promulgated a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act, although they are neither the subject of an applicable United States Pharmacopeia or National Formulary monograph nor components of FDA-approved drugs. This proposed rule would amend that list by placing five additional bulk drug substances on the list. This proposed rule also identifies 26 bulk drug substances that FDA has considered and proposes not to include on the list.
Regulatory Impact Analysis
Amendments to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) PRIA Document (PDF - 170KB)
Federal Register: 84 FR 46688, September 5, 2019