Hamburg said the agency needs new, stronger and clearer legislation to oversee “firms engaged in large-scale distribution” of custom-mixed, or compounded, drugs, some of which were highlighted in the Post article. The current patchwork of federal and state laws is too weak to protect patients in all 50 states from high-risk compounding operations, she said in a statement.
“We’ve reached a critical point on this issue,” Hamburg said.
Rep. Edward Markey, D-Mass., who released a report last fall showing uneven oversight by state authorities, said Friday that the FDA needs greater authority. He plans to reintroduce legislation that would allow the agency to regulate compounders that act more like drug manufacturers.
“These compounding pharmacies have been operating under the radar for too long,” he said in a statement.
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