FDA Revision of USP 561

New Compounds and Procedures for Pesticide Impurities in Dietary Supplements and Pharmaceuticals

Changes to pesticide residue test procedures for the analysis of dietary supplements and pharmaceuticals have been incorporated in the new monograph <561> (Articles of Botanical Origin) of USP 34, effective May 1, 2011. The new monograph includes approximately 108 pesticides, involving twice as many as the previous one. These changes have also resulted in the harmonization with the European Pharmacopoeia 7.0 regulations. The revisions are designed to promote the safety and well-being of the public. Many in the dietary supplement and pharmaceutical industries may have concerns about the more stringent requirements and the extra costs associated with the additional testing. Nonetheless, the revisions should have a beneficial impact on the industries, resulting in safer, higher quality products.

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