Quality Guidance for Homeopathic Manufacturers

Newton Square, PA, August 18, 2009 — The American Association of Homeopathic Pharmacists (AAHP) is reminding manufacturers of homeopathic drugs to take additional steps to ensure the safety of their products. This action is in response to the US Food and Drug Administration’s recently released Guidance for Industry entitled Pharmaceutical Components at Risk for Melamine Contamination. The guidance highlights the need to test possible at-risk components, including lactose, which is a material frequently used in homeopathic solid dose products. This action is in response to reports from China to the FDA in September of 2008, indicating that food articles had been contaminated with melamine.

“Homeopathic manufacturers need to review the list of at-risk ingredients and determine whether they are using any of them in their manufacturing processes, “ commented Mark Phillips, President and COO of Standard Homeopathic Company and Hyland’s, Inc. “ Manufacturers must put in place appropriate testing methods to detect and eliminate the possibility of using melamine contaminated materials. Method development, training, and implementation are all necessary and timely execution by companies will ensure both safety and the steady flow of homeopathic products to the marketplace”

The guidance document provides recommendations that will help homeopathic manufacturers better control their use of at-risk components that might be contaminated with melamine (a nitrogen-based compound). The guidance 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 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.