Issue Date: August 6, 2009
Issued by: Center for Veterinary Medicine
Topic(s): Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final
Pharmaceutical Components at Risk for Melamine Contamination: Guidance for Industry
This guidance is intended to alert pharmaceutical manufacturers of finished products, pharmacy compounders, repackers, and suppliers to the potential risk of melamine contamination in pharmaceutical components. In September 2008, FDA received reports from China about food articles contaminated with melamine, which have resulted in thousands of hospitalizations for kidney problems and at least three deaths. As of the date of this guidance, FDA is not aware of any pharmaceuticals that have been contaminated with melamine. However, because of the potential risk of drug contamination, it is important that manufacturers take steps to ensure that susceptible components are not contaminated with melamine.
Download the Guidance Document
