How Are Homeopathic Medicines Regulated in the USA?
A. Homeopathic medicines are regulated as drugs by the US Food and Drug Administration (FDA). The Homeopathic Pharmacopoeia of the United States (HPUS) was written into federal law in 1938 under the Federal Food, Drug, and Cosmetic Act. The HPUS tells homeopathic medicine manufacturers exactly how the individual homeopathic medicines must be made. All homeopathic medicine manufacturers in the US (including WHP) must manufacture in accordance with the guidelines set out by the HPUS. Homeopathic pharmacies and manufacturers are inspected by the FDA just like other pharmacies and must comply with all Good Manufacturing Practice standards. While most homeopathic medicines are designated by the FDA as “over-the-counter” drugs, and thus allowed to be sold in health food stores and to the general public, some homeopathic medicines are designated “prescription” Rx drugs. These Rx homeopathic medicines are available only to licensed practitioners with Rx prescription authority.
