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FDAnews Drug Daily Bulletin
FDA Advises Melamine Tests for At-Risk Components
Aug. 12, 2009
Drugmakers should determine if they are using components possibly contaminated with melamine and test those found at risk, as well as make sure they get certifications from suppliers that at-risk components have been tested appropriately. A new guidance
issued last week lists 27 components the agency considers to be at risk of melamine contamination based on its search of U.S. Pharmacopeia/National Formulary monographs and its Inactive Ingredient Database. The list — which includes adenine, ammonium salts, gelatin, guar gum, lactose, povidone and taurine — is not all-inclusive, the guidance says.
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