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Comments on the FDA’s Draft Interim Policy on Compounding Drugs Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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Public Citizen objects to the Food and Drug Administration’s (FDA’s) proposed interim policy that will allow outsourcing facilities to mass-produce drugs using bulk drug substances that are not currently on a list of drug shortages maintained by the FDA or on a list of bulk drug substances for which there is a clinical need. The proposed interim policy poses a threat to public health.