FDA issues guidance on melamine contamination prevention

The US Food and Drug Administration (FDA) is advising that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilisers and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although the FDA says it has no reason to believe the US pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the US, and milk products for infants in China, highlight the potential problem.

The Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination is an initial measure in working with pharmaceutical manufacturers, repackers, other suppliers and pharmacists to conduct melamine testing.

"The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain," said commissioner of food and drugs, Margaret Hamburg. "We look forward to working with industry on this serious public health concern."

The FDA recommends that specific pharmaceutical ingredients be screened for the presence of melamine. It suggests using FDA-published methods that detect the presence of melamine in food proteins. These tests rely on equipment that is generally available to pharmaceutical manufacturers or contract testing labs. The agency is also developing a sampling and testing programme for pharmaceutical ingredients at risk from melamine contamination.

Comments on the guidance, identified with docket number FDA-2009-D-0354, may be submitted electronically to the FDA.