Comments on the FDA’s Proposal to Amend the List of Bulk Drug Substances That Can be Used to Compound Drug Products Under Section 503A of the FDCA

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Regarding the Food and Drug Administration’s (FDA’s) proposal to add five bulk drug substances to the list of bulk drug substances that can be used to compound drug products under section 503A of the Food, Drug, and Cosmetic Act (FDCA), Public Citizen supports adding three of the bulk drug substances and opposes adding two. Public Citizen also strongly supports the FDA’s proposal to exclude 26 bulk drug substances from the list because of concerns regarding the substances’ safety or effectiveness.

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