John P Borneman1, Robert I Field. 1. Homeopathic Pharmacopoeia Convention of the United States, Southeastern, PA, USA. jborneman@hylands.com
Abstract
PURPOSE: The regulation of homeopathic drug products is discussed. SUMMARY: Homeopathy is a system of medicine based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. These same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies. Unlike dietary supplements, homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homeopathic Pharmacopoeia of the United States (HPUS). The criteria for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective and to be prepared according to the specifications of the HPUS general pharmacy section. The long history and established nature of homeopathic drug regulation may provide a model for the regulation of dietary supplements. CONCLUSION: Homeopathic drugs in the United States are subject to well-defined regulatory processes that more closely resemble those that apply to allopathic medications than to dietary supplements.
PURPOSE: The regulation of homeopathic drug products is discussed. SUMMARY: Homeopathy is a system of medicine based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. These same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies. Unlike dietary supplements, homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homeopathic Pharmacopoeia of the United States (HPUS). The criteria for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective and to be prepared according to the specifications of the HPUS general pharmacy section. The long history and established nature of homeopathic drug regulation may provide a model for the regulation of dietary supplements. CONCLUSION: Homeopathic drugs in the United States are subject to well-defined regulatory processes that more closely resemble those that apply to allopathic medications than to dietary supplements.