Homeopathic Pharmacopoeia of the United States
The Homœopathic Pharmacopoeia of the United States has been in continuous publication since 1897, when it was first published by the Committee on Pharmacy of the American Institute of Homeopathy. The 1897 publication had been preceded by a number of other volumes with similar purposes, including Gruner and Jahr’s Homeopathica Polyglotta, and Boericke & Tafel’s various editions of The American Homeopathic Pharmacopoeia. Beginning in 1980, the HPUS has been published by the Homœopathic Pharmacopeia Convention of the United States. For more details, please see the Publication History.
The HPUS is specifically designed to constitute a continuously updated statement of Homeopathic Pharmacopoeia standards and monographs. To support this objective, the current HPUS is only available as an on-line reference for the identity and quality standards of homeopathic starting materials and the manufacture of homeopathic drug products. It is the official compendium recognized by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act for homeopathic drug products.
The HPUS is produced from the standpoint of safety, and standardization; it establishes criteria that identify those drugs that are potentially toxic, and which indicate first permissible attenuation levels in which those drugs may be sold.
The HPCUS Board appoints several committees to assist in its work: the Monograph Review Committee, the Pharmacopoeia Revision Committee, the Council on Pharmacy, the Toxicology and Safety Committee, and the Standards and Controls Committee. These committees are composed of experts in the fields of medicine, pharmacy, biology, botany, and chemistry who have had appropriate training and experience and have demonstrated additional knowledge and interest in the principles of homeopathy. The experts meet multiple times a year to review monographs (which each contain information about specific homeopathic starting materials) and guideline documents (which provide standards for the manufacture and labeling of homeopathic drug products).
For a substance to be included in the HPUS as an official homeopathic drug product, it must have sufficient clinical data or homeopathic proving to demonstrate its clinical usefulness in accordance with homeopathic therapeutic principles; it must also be shown to be safe at the considered attenuation level. A decision to include a homeopathic drug product in the HPUS is made by the HPCUS Board of Directors after a thorough review by relevant committees. The review process is very formal, as are the criteria for acceptance. For more details, see Monograph Review Process
Homeopathy
Homeopathy is the art and the science of healing the sick by using substances capable of causing the same symptoms, syndromes, and conditions when administered to healthy people. These substances may be of mineral, synthetic, or biological (animal or botanical) origin and are made in rigorously prepared small doses.
Any substance may be considered a homeopathic medicine if it has known “homeopathic provings” and/or known effects which mimic the symptoms, syndromes or conditions which it is administered to treat, and is manufactured according to the specifications of the Homeopathic Pharmacopoeia of the United States (HPUS). Official homeopathic drugs are those that have been monographed and accepted for inclusion in the HPUS. See Criteria for Eligibility of Drugs for Inclusion for more information.
Homeopathy may be used for self-treatment of symptoms associated with self-limiting conditions as the selection of the proper medicine is dependent on the symptoms that the body exhibits in its reaction to the illness. However, treatment of conditions which are serious and / or not self-limiting, should be undertaken only under the care of a health care practitioner well-versed in homeopathy.
Official vs. Non-Official
By statute, any homeopathic drug monographed in the HPUS is considered “official”. The US Food and Drug Administration, as a matter of policy, refers to the HPUS monographs to determine what substances it will consider as “homeopathic.” Those not monographed in the HPUS are “non-official.” While non-official homeopathic drugs may be marketed, there are substantial burdens on the marketer and manufacturer to properly address the homeopathic nature of a non-official homeopathic drug product, as well as the burden of assessing and documenting the safety of the product in the marketed attenuation; in addition, the marketer and manufacturer must have full documentation to substantiate scientifically justifiable standards for their identity and quality criteria of any non-official homeopathic drug products.
OTC vs Rx-Only
Currently, there are over 1,300 officially monographed homeopathic drug substances in the Pharmacopeia. The HPUS establishes guidelines which set forth the levels of attenuation (dilution) which are appropriate for OTC sale (may be sold over the counter without a prescription) or RX-only (restricted to sale only upon receipt of a prescription from an appropriately licensed medical provider). Close to half of monographed drugs are restricted to Rx-only sale in at least one attenuation, and a very small percentage are classified as Rx-only in all attenuations. OTC/RX-only status is determined by criteria based on appropriate OTC uses for the product; in addition, the particular attenuation which is being marketed should be non-toxic for it to be classed OTC. For more details, see Explanation of Attenuation Levels (accessible by subscription only).
When considering the distinction between OTC and RX-only, one is compelled to consider the consumer in a retail setting, rather than a trained homeopath. This may cause some confusion in relation to licensure; many individuals are competently trained to use homeopathic drug products yet lack the necessary license to obtain RX-only homeopathic attenuations. This is a circumstance clearly beyond the role of the HPCUS to address, as the regulatory environment impacts all medicinal products, not just homeopathic drugs.
Legal Status and Commercial Availability of Some Monographed Legacy Substances
The existence of a monograph in the HPUS for a particular homeopathic substance is not a representation by the HPCUS that that substance is legally or commercially available in the United States. HPUS subscribers are responsible for determining the legal requirements for the use of any monographed substance. The use of some monographed substances, for example, may be restricted by law or regulations of the Drug Enforcement Administration and the Food and Drug Administration. Similarly, some may be restricted by state and local regulations. Some products may not be available because of restrictions on obtaining the starting material due to their endangered status.
The HPUS has chosen to continue to publish the monographs for these legacy substances for historical purposes, for whatever value they may have outside the United States, and in the event their legal status changes in the future.
A Note on Spelling
Which is correct, or appropriate, in our day and age: Homœopathy or Homeopathy?
Standard dictionaries recognize both spellings. There is no question the original Greek root-word has the -οι diphthong, which would transliterate with homœopathy. The Oxford English Dictionary (OED), an historical reference tracing word usage over the centuries, takes the more traditional line, listing it under “homœopathy” (but still acknowledging the diphthong-less spelling). On the other hand, the American Heritage dictionary uses the entry homeopathy and reflects the common spelling in the United States.
Both spellings have a long history of use in English. According to the OED, “homœopathy” originally appeared in print in an English language text in 1838 (Penny Cycl. XII. 277/2) while “homeopathy” appeared less than a decade later in 1847 (J. Craig New Universal Dict.). The anglicized spelling, without the diphthong, gradually became the predominant spelling in the United States, an historical evolution that has parallels with other words originally containing the diphthong, such as oedema, eupnoea and oecology.
Based on common usage in this country, the limitations of modern keyboards, and the familiarity of contemporary typists, the Convention has determined to use the homeopathy spelling throughout its texts, and reserves the use of the diphthong spelling of Homœopathy to the name of the Convention and the pharmacopeia (including the logo) in limited circumstances where appropriate to match certain legal documents.