Comments to Senate Committee on Health, Education, Labor, and Pensions on the FDA’s Flawed Proposal for Oversight of Compounding

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Testimony of William P. Kennedy before Senate Committee on Health, Education, Labor & Pensions Hearing on Pharmacy Compounding, October 23, 2003

In response to the recent fungal meningitis outbreak, the FDA proposed a new regulatory framework for compounding pharmacies that would weaken, rather than strengthen, existing laws governing drug manufacturing. Public Citizen believes it wiser to strengthen existing laws by clarifying the line between traditional pharmacy compounding and drug manufacturing and clarifying the federal standards governing traditional compounding. All drug manufactures must be held to the same rigorous safety and quality standards.