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Comments on the FDA’s Draft Guidance Regarding Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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In general, Public Citizen strongly supports the policies proposed in the draft guidance document. In particular, the proposed guidance seeks to appropriately limit, under section 503B, the use of bulk drug substances by outsourcing facilities in pharmacy compounding of human drug products that are not on the FDA’s drug shortage list.

See Public Citizen’s other work on pharmacy compounding.