Advocacy group says proposed compounding regulations would endanger public health

Public Citizen criticizes FDA commissioner's proposal

WASHINGTON — An advocacy group said proposed Food and Drug Administration rules for compounding pharmacies would put the public's health and safety at risk.

In a letter sent to Department of Health and Human Services secretary Kathleen Sebelius, Public Citizen criticized Food and Drug Administration commissioner Margaret Hamburg for "both undermining her agency's authority in congressional testimony last month and offering a plan that would effectively weaken the agency's oversight of drug manufacturing."

In testimony before the House Committee on Energy and Commerce last month, Hamburg proposed giving the FDA new power to regulate pharmacy compounding and creating two tiers for compounding: traditional and nontraditional. Traditional would include custom-made medicines for patients with individualized medical needs, while nontraditional compounding would cover compounding that some say effectively amounts to drug manufacturing. Public Citizen said the proposed rules would weaken existing regulations of drug manufacturers and create "substandard requirements" for compounding pharmacies.

The proposed new regulations were made in the wake of an outbreak of fungal meningitis linked to the New England Compounding Center of Framingham, Mass., which has so sickened 620 people and killed 39 in 19 states, according to the Centers for Disease Control and Prevention.

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