HPUS: The Legal and Technical Backbone of Homeopathy
By Mark Land, M.S., RAC-US, AAHP President
The Homeopathic Pharmacopoeia of the United States (HPUS) is the legal basis for marketing homeopathic drug products in the United States and many other countries around the world. The HPUS is officially recognized in the United States Federal Food, Drug, and Cosmetic Act and other United States laws. As such, the HPUS is considered an Official Compendium, and drug substances referenced therein are officially recognized as drugs. Al Lorman, AAHP Counsel, takes a deeper dive into the legal basis and the role of the HPUS in his article in this issue. Read more.
Beyond monographing more than 1,300 substances, the HPUS offers other vital information specific to procuring, producing, and packaging homeopathic products such as guidelines on GMPs and stability testing specifically for homeopathic drug products. Check out this exclusive interview with long-time leader within the HPCUS Eric L. Foxman, R.Ph. (Ret.) on valuable resources within the HPUS.
In April of this year, the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) held its 45th annual meeting. This year’s discussions focused on 1) the impact of reduction in the workforce at FDA and 2) a deeper implementation of HPCUS’ centralized filing system.
In this issue we publish an enlightening timeline of the HPUS since its founding in the late 19th century. The HPUS has been in continuous publication and revision since 1897 — originally published by the American Institute of Homeopathy (AIH). In conversations with representatives of AIH, I learned that a strong instinct towards and protection of the quality of homeopathic medicines remains alive in their organization.
Today, the HPUS is published online and is continuously updated by multiple working committees of the HPCUS. The HPUS publishes standards for identity, quality, safety, manufacturing, and testing. These standards become the basis of activity within individual manufacturing facilities and the reference for regulatory inspections.
A recent development is work being done to develop a National Homeopathic Product Certification Board. This effort aims to establish community consensus standards for homeopathic products marketed in the United States. The aim is admirable but should look to reinforce and not sidestep the position and standards of the HPUS.
Drug GMPs require that all facilities manufacturing homeopathic drugs have access to the HPUS and reference its standards for manufacturing and testing procedures. All AAHP members are required to maintain a subscription to the HPUS.
The importance of the HPUS cannot be overstated for homeopathic manufacturing and marketing organizations. Remain fresh and up to date! Look for future webinars from AAHP on updates to the HPUS.