Some Notes on Homeopathic Pharmacopeia

Stephen Barrett, M.D.
October 11, 2015

The first eight editions of the Homeopathic Pharmacopoeia of the United States (HPUS) were published by the Committee on Pharmacy of the American Institute of Homeopathy in 1897, 1901, 1914, 1936, 1938, 1941, 1964, and 1978. In December 1980, the United States Homoeopathic Pharmacopoeia Convention of the United States (HPCUS) assumed responsibility for future publication. The HPCUS published Supplement “A” of the HPUS Eighth Edition in 1982. Subsequently, it decided to combine the supplement, the 1978 HPUS, and the 1974 Compendium of Homeo-therapeutics into one compilation to be known as the Homeopathic Pharmacopoeia of the United States/Revision Service (HPRS), which was issued as a set of looseleaf volumes that was sold on a subscription basis so that additions and revisions could be inserted each year. Since 2004, the book and updates have been published online.

The 1938 Food, Drug, and Cosmetic Act recognized all substances listed in the HPUS as drugs. The current version includes monographs for about 1,300 substances. Each monograph contains the current name of the substance, any synonyms, and how the drug product is prepared (preparation type and dilution). For plant-based and animal-based products, the biological classification, habitat, and a description that includes the part(s) used are also included. For mineral products, the chemical formula and molecular weight are specified.

The HPUS Web site states that to be eligible for inclusion, the substance must meet criteria 1, 2, 3, and at least one of 4, 5, 6, or 7 in the following list:

  1. The HPCUS has determined that the drug is safe and effective.
  2. The drug must be prepared according to the specifications of the General Pharmacy and relevant sections of the Homeopathic Pharmacopeia of the United States.
  3. The submitted documentation must be in an approved format as set forth in the relevant sections of the Homeopathic Pharmacopeia of the United States.
  4. The therapeutic use of a new and non-official homeopathic drug is established by a homeopathic drug proving and clinical verification acceptable to the HPCUS. During the period of clinical verification the drug will be accepted for provisional review and should be available on a monitored basis. Refer to the guideline for Homeopathic Drug Provings and the guideline for Clinical Verification for further information.
  5. The therapeutic use of the drug is established through published documentation that the substance was in use prior to 1962. This documentation must include the symptom picture, including subjective and any available objective symptoms. Such use and documentation may include but are not limited to the medical literature of the following homeopathic authors: S. Hahnemann, C. Hering, T.F. Allen, H.C. Allen, J.H. Clarke, and J.T. Kent.
  6. The therapeutic use of the drug is established by at least two adequately controlled double blind clinical studies using the drug as the single intervention; the study is to be accompanied by adequate statistical analysis and adequate description of the symptom picture acceptable to the HPCUS which includes the subjective symptoms and, where appropriate, the objective symptomatology.
  7. The therapeutic use of the drug is established by a) data gathered from clinical experience encompassing the symptom picture, pre- and post-treatment, including subjective and any available objective symptoms or b) data documented in the medical literature (all sources of medical literature may be considered on a case by case basis) subjected to further verification (statistical and/or other forms of verification).

Unfortunately for the public, HPCUS’s criteria for determining safety and effectiveness in item #1 are not based on scientific principles. Modern scientific testing requires well-designed, controlled experiments in which people who receive the drug are compared to similar people who do not. But homeopathic determinations are based on “provings” in which people recorded what they felt after swallowing a substance, these experiences were compiled long ago into books called materia medica, and the substances were then assumed to cure conditions with similar symptoms.

HPUS monographs say nothing about any alleged medicinal purposes of the products. That is determined by homeopathic practitioners and product manufacturers who rely on materia medica.

This article was revised on October 11, 2015.