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.

This lecture attempts to analyse the progress made by homeopathy in recent years, by analysing consumer awareness, sales and distribution trends of homeopathic products, and research publications. Sales of homeopathic medicines are growing rapidly, but remain a very small fraction of the total pharmaceutical market. The proportion of combination to single medicines varies widely between countries. The market is concentrated in a relatively small number of the available medicines; many available homeopathic medicines are never used. Regulation of homeopathic practitioners and medicines is problematic, the legal position varies between countries. The volume of research is growing steadily. A series of recommendations is made, including modernisation of the terminology of homeopathy, training of more practitioners, a defined research agenda and integration into the medical system.

This lecture attempts to analyse the progress made by homeopathy in recent years, by analysing consumer awareness, sales and distribution trends of homeopathic products, and research publications. Sales of homeopathic medicines are growing rapidly, but remain a very small fraction of the total pharmaceutical market. The proportion of combination to single medicines varies widely between countries. The market is concentrated in a relatively small number of the available medicines; many available homeopathic medicines are never used. Regulation of homeopathic practitioners and medicines is problematic, the legal position varies between countries. The volume of research is growing steadily. A series of recommendations is made, including modernisation of the terminology of homeopathy, training of more practitioners, a defined research agenda and integration into the medical system.