The United States Homoeopathic Pharmacopoeia (HPUS) is a pivotal document that serves as the official compendium for homeopathic medicines in the United States. First published in 1897 by the American Institute of Homeopathy, it has undergone continuous revisions to ensure the safety, efficacy, and quality of homeopathic drug products. The HPUS is recognized under the Federal Food, Drug, and Cosmetic Act of 1938, making it a legally binding standard for the manufacture and marketing of homeopathic medicines in the U.S. .
Managed by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), the HPUS is developed and updated by various expert committees. These include the Monograph Review Committee, the Pharmacopoeia Revision Committee, the Council on Pharmacy, the Safety and Toxicology Committee, and the Standards and Controls Committee. These committees are composed of professionals with expertise in medicine, pharmacy, biology, botany, and chemistry. They collaborate to review and establish standards for homeopathic substances, ensuring that each monograph provides detailed information on the identity, quality, safety, manufacturing, and testing of homeopathic drug products .
The HPUS categorizes homeopathic medicines into “official” and “non-official” substances. Only those substances that are monographed in the HPUS are considered official, meaning they meet the rigorous standards set forth by the compendium. The inclusion of a substance in the HPUS requires substantial clinical data or homeopathic proving to demonstrate its therapeutic efficacy and safety at specified attenuation levels. Non-official substances, while they may be marketed, do not have the same legal standing and may require additional documentation to substantiate their safety and quality.
The HPUS is an essential resource for ensuring the quality and safety of homeopathic medicines in the United States. Through its comprehensive standards and rigorous review process, it upholds the principles of homeopathy while adapting to contemporary scientific and regulatory advancements. The ongoing work of the HPCUS and its committees reflects a commitment to maintaining the integrity and efficacy of homeopathic treatments for the public.