Obama signs drug compounding bill

President Obama signed legislation on Wednesday that will give the Food and Drug Administration (FDA) new powers to oversee some pharmacies that mix drugs.

The Drug Quality and Security Act would make it easier to trace drugs throughout the country.

It was introduced by Rep. Fred Upton (R-Mich.) in the wake of an outbreak of fungal meningitis linked to a Massachusetts drug compounding facility. The outbreak killed 64 people last year.

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The bill passed through the Senate on a voice-vote last week. The House gave its approval to the measure in September.

Under the bill, large outsourcing compound pharmacies, which mix drugs to create customized batches of medicine, would fall under the FDA’s supervision. State boards of pharmacy would watch over traditional, smaller facilities.

The legislation also calls for a national tracking system to monitor the drug supply chain and crack down on counterfeits.

Some consumer interest groups had expressed concerns about the legislation, saying that it could allow some facilities to escape FDA regulations.

The Obama administration has also expressed reservations. Earlier this month, FDA Commissioner Margaret Hamburg said that the bill is “a step” but would not be “as comprehensive as we initially had hoped.” 

 

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