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Published on 6 November 2007

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Illegal drugs seized by regulator

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Officials in America have seized illegal pharmaceuticals worth more than $300,000 in an operation overseen by the Food and Drug Administration (FDA).

US Marshals impounded the drugs, including NC Solution, an antifungal product, and other compounds for human and animal use, dietary supplements, and their ingredients.

Some of the drugs did not have FDA approval, and all were maintained in allegedly unsanitary conditions by General Therapeutics, which is based in St Louis.

The FDA considers NC Solution to be a drug because it is intended for the use in the diagnosis, cure, or treatment of disease in people or animals.

NC Solution is also a new drug because it is not generally recognised as safe and effective for its intended uses.

Before a new drug product may be legally marketed, it must be approved by the FDA, but General Therapeutics does not have approval to make NC Solution.

Back in the summer, FDA inspectors found that the company was manufacturing drugs and dietary supplements in unsanitary conditions, and found insects and rodent filth on the factory floor.

Margaret Glavin, the FDA’s associate commissioner for regulatory affairs, said: “The action taken is the culmination of the concerted efforts by the FDA to get the firm to follow the law when it comes to manufacturing safe products for consumers.”

Copyright © PA Business 2007

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