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

View as PDF

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.