Public Citizen Asks the Food and Drug Administration (FDA) to Clarify the Line Between Pharmacy Compounding and Drug Manufacturing

February 3, 2014

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Public Citizen provided comments to the FDA regarding the agency’s draft guidance on pharmacy compounding under section 503A of the Food, Drug and Cosmetics Act. Although generally supportive of the guidance, Public Citizen raises the concern that the existing draft fails to clarify the main statutory criteria distinguishing between compounded drugs, which are intended to be individually tailored for a specifically identified patient to meet a unique or unusual clinical need, and manufactured drugs, which are mass-produced, standardized products intended for a population that shares a common set of clinical needs.