Federal Register Notice: FDA is making available a guidance for industry, Pharmaceutical Components at Risk for Melamine Contamination. It will provide recommendations to aid pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding in avoiding the use of components that are at risk for melamine contamination.

FDA is recommending that at-risk components be properly tested for melamine contamination before they are used in the manufacture or preparation of drugs or drug products. This recommendation applies to nitrogen-based components. The agency has posted on its Web site methods for measuring melamine contamination in foods using liquid chromatography triple quadrupole tandem mass spectrometry and gas chromatography/mass spectrometry. To download this guidance, click here. To view this notice, click here.