September 22, 2017
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House passes bill to regulate drug compounding

By Reuters

WASHINGTON — The House of Representatives on Saturday passed legislation that would give the Food and Drug Administration more authority to regulate companies that compound sterile drugs and ship them across state lines.

The bill, called the Drug Quality and Security Act, now goes to the Senate for a vote. House and Senate committees agreed on the legislation on Wednesday.

Introduced after a deadly outbreak of fungal meningitis killed more than 50 people last year, the act would also create a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medication into the drug supply.

The fungal meningitis outbreak was traced to a tainted steroid sold by the New England Compounding Center in Framingham, Mass.

Complaints from companies that felt previously proposed laws would cost too much to implement helped derail earlier attempts to create such national standards to track and trace drugs.

 


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