FDA Issues Pharmaceutical Industry Melamine Testing Guidance

In a guidance issued Aug. 6, the Food and Drug Administration says 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, foams, cleaning products, fertilizers, and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the United States, and milk products for infants in China, underscore the potential problem.

The guidance is an initial measure by the agency in working with pharmaceutical manufacturers, repackers, other suppliers, and pharmacists to conduct melamine testing. The agency invites comments on the guidance, available online and titled "Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination."

"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 A. Hamburg, M.D. "We look forward to working with industry on this serious public health concern."

FDA identifies specific pharmaceutical ingredients in the guidance that are recommended to be screened for the presence of melamine. The guidance also recommends the use of FDA-published methods for this testing that are used to 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 also is developing a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

Comments may be submitted electronically at www.regulations.gov or by mail to FDA, Division of Dockets Management (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with docket number FDA-2009-D-0354.

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