To implement the Drug Quality and Security Act, which President Barack Obama signed last week, the FDA released three draft guidance documents on Monday that outline the process for registering outsourcing facilities and for listing the drugs they produce.
The need for the legislation came after 64 people died and hundreds became seriously ill across 20 states last year from tainted steroid injections produced by the New England Compounding Center, a now-closed compounding pharmacy in Framingham, Mass.
The agency remains concerned that the law does not make it mandatory that large compounding pharmacies register, which means the government still may not be able to address life-threatening quality problems before it's too late.
“There does remain some uncertainty that if a company doesn't choose to register with us, how will we be aware of them if there are problems?” FDA Commissioner Margaret Hamburg said.
Without a registration mandate, the federal agency will have to rely on state officials to provide information on facilities in their region.
As Congress moved toward voting on the legislation, Hamburg voiced concerns that it wasn't “going to be as comprehensive as we initially had hoped.”
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