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U.S. FDA urged drug screening melamine production

9 August 2009 1,615 views No Comment

WASHINGTON — The FDA has called for routine testing for melamine contamination in certain ingredients used in the manufacture and preparation of drugs.

If consumed in sufficient amounts, the chemical — used in the industrial production of resins, cleaning products, fertilizers, and pesticides — can cause kidney failure and death.

The FDA recommended screening the pharmaceutical ingredients with methods currently used for testing food proteins. The equipment necessary is generally available to drug manufacturers and contract testing labs, the agency said.

There is “no reason to believe that the U.S. pharmaceutical supply is contaminated,” the FDA said in a news release, calling the move a precautionary step.

Last fall, following reports of melamine in infant formula in China, the FDA recalled a number of food products, including instant coffees, teas, and baby formulas, due to melamine contamination. (See Chinese Melamine Contamination Triggers U.S. Recall of Coffee and Tea Products)

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” Margaret A. Hamburg, MD, commissioner of food and drugs, said in an agency brief.

The guide containing these new screening methods, “Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination,” is available on the FDA website.
                                                                                                                                     By Cole Petrochko

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