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.
Washington Drug Letter
Washington Drug Letter
