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August 10th, 2009
US FDA Communicates Melamine Testing Recommendations

The US FDA recently issued a recommendation advising that certain pharmaceutical components used in the production or composition of drug products should be tested for melamine.

What is melamine? Melamine is a man-made chemical with a range of commercial uses, such as in the construction of resins and foams, cleaning solutions, fertilizers and pesticides.  If enough Melamine is swallowed, a person can suffer from kidney failure and possible death.

Despite the fact there has not been any reports or reason to believe that the US pharmaceuticals stock is tainted with melamine, the US FDA maintains precautionary measures because of recent events involving local pet and livestock food products, and infant milk products in China.

The FDA’s recommendations is a preliminary procedure to work with pharmaceutical producers, re-packers, other suppliers and pharmacists to begin melamine evaluations.  Commissioner of Food and Drugs Margaret A. Hamburg MD, says “The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain.”

The US FDA has discerned particular pharmaceutical components in their recommendation that they suggest be tested for melamine.  The recommendation also suggests that FDA – published methods of melamine detection in foods and proteins are applied.  Although, the tests rely on machinery, these types of machines are commonly available to pharmaceutical manufacturers and contract testing labs. Currently, the FDA is also expanding to develop a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.


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