FDA Issues Guidance on Monitoring At-Risk Melamine Contamination

The US Food and Drug Administration released its Guidance for Industry entitled Pharmaceutical Components at Risk for Melamine Contamination. The document provides recommendations that will help pharmaceutical manufacturers better control their use of at-risk components that might be contaminated with melamine (a nitrogen-based compound). The agency considers “at-risk components” to be those ingredients or raw materials that rely on a test for nitrogen content for their identity, purity, or strength and that contain nitrogen in amounts greater than 2.5%.

In September 2008, FDA received reports from China indicating that food articles had been contaminated with melamine. To date, the agency has not received information regarding any pharmaceutical products that have been contaminated with melamine.

According to the guidance, “It is critical that all manufacturers determine whether they are using an at-risk component for melamine contamination to manufacture or prepare a drug product.” The document provides a list of such components and explains how these components were identified. FDA recommends that finished-product manufacturers monitor their supply chain for at-risk components, including knowing the identity and role of the actual manufacturer of these components and any repackers and distributers who handle the components. The agency recommends that finished-product manufacturers audit their component suppliers to ensure compliance with current good manufacturing practices and obtain certification from the manufacturers of at-risk components that the components are tested for melamine contamination.