Comments on the FDA’s Proposal to Exclude Nine Drugs From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities

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Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to exclude nine bulk drug substances from the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act for pharmacy compounding by outsourcing facilities. Each of the nominated bulk drug substances is a component of one or more FDA-approved drug products, and the nominators have failed to demonstrate that there is a clinical need for outsourcing facilities to compound drug products using the nominated bulk drug substances.

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