Public Citizen, a consumer advocacy group, urged HHS Secretary Kathleen Sebelius to reject the FDA's proposed two-tier framework for regulating compounding pharmacies. "The FDA's proposal for oversight of 'non-traditional' compounding, if implemented, would decriminalize what is now illegal drug manufacturing conducted under the guise of pharmacy compounding, and ensure the continuing occurrence of serious disease outbreaks caused by tainted drugs in the future," Public Citizen's Dr. Michael Carome said in a statement.

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