By Mark Land, AAHP President
The first edition of the Homeopathic Pharmacopoeia of the United States (HPUS) was first published in 1897 — 125 years ago! Since FDA’s 2019 draft guidance defines a homeopathic drug product as one labeled as homeopathic and containing active ingredients and dilutions referenced within the HPUS, it’s more crucial than ever to be up to date with the annual changes made to these standards.
Eight editions of the HPUS were published by the American Institute of Homeopathy (AIH). Then in 1980, the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) was formed. I have been involved with the Convention for nearly 20 years.
During that time, I have witnessed a dramatic improvement in the quality of the Pharmacopoeia. Jack Borneman, one of the first presidents of the Convention, said that one of the principal points of agreement between the Food and Drug Administration (FDA) and the HPCUS in the early 1980s was that the HPUS required updating of monograph nomenclature, descriptions, and test methods. As someone using the eighth edition of the Pharmacopoeia at that time, I certainly agreed with that assessment.
Working on those things has been an ongoing process over the past 42 years. In addition, the Pharmacopoeia has published Guidelines for Manufacturing Homeopathic Medicines, Good Manufacturing Practices, Stability, Labeling, Provings, and Clinical Verification. In addition, 803 monographs have been revised with updated nomenclature, descriptions, and quality control test methods.
Much like the early 1980s, both FDA and HPCUS continue to agree that the Pharmacopoeia could benefit from improvements. Unlike earlier times, the mandate today is not only to improve the quality of the content, but also to make the processes and procedures of the Pharmacopoeia more reliable, transparent, and visible. The most recent Convention meeting was focused on infrastructure and organizational improvements to meet the expectations of both FDA, the homeopathic community, and the Convention itself.
Also similar to the 1980s is the current vitality of the Pharmacopoeia—not just in terms of the number of people working within the Convention or their enthusiasm, but the crucial role the Pharmacopoeia and the Convention play in regulating the products we make and sell. In the 2019 revision to FDA’s draft guidance Drug Products Labeled as Homeopathic, FDA defined a homeopathic drug product as one labeled as homeopathic and containing active ingredients and dilutions referenced within the HPUS. To my way of thinking, this is a signal of the reliance FDA is placing on the HPUS.
The Convention has responded to that expectation with a project, consisting of five white papers, that aims to close technical gaps in areas critical to both FDA and the manufacturing industry. FDA has been engaged in this project, and the Convention has welcomed new experts in these areas to help in the process. These are welcome signs of vitality and commitment to the quality of the products we make.
Toward the goal of transparency and reliability, the Convention is close to finalizing updates to its computer system infrastructure and is documenting the procedures of all committees. For an organization of this type, that might sound rather mundane. In this case however, addressing these two areas of governance required deep reflection and a great deal of work.
One area of discussion during a recent Convention meeting was HPCUS funding. The Convention is considering outreach to multiple constituencies within the homeopathic community for funding. Please consider including the HPCUS on your giving list.