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

December 22, 2015

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Public Citizen objects to the Food and Drug Administration's (FDA's) proposed interim policy that will allow pharmacies to compound drugs using bulk drug substances that that are not components of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act, the subject of U.S. Pharmacopeia or National Formulary monographs, or drug substances appearing on the 503A bulk list while the agency undertakes the task of evaluating nominations for the 503A bulk list. The proposed interim policy poses a threat to public health.