By Eric L. Foxman, R.Ph., senior scientist, HPCUS
Homeopathic pharmacopoeias have been published continually since the 1840s. The Homeopathic Pharmacopoeia of the United States (HPUS) has been in continuous publication for more than 125 years — since 1897. It became officially recognized under the U.S. Food Drug and Cosmetic Act in 1938 and was published by the American Institute of Homeopathy until the formation of the Homœopathic Pharmacopœia Convention of the United States (HPCUS) in 1980.
The HPUS provides a clear set of standards for the manufacturer of homeopathic drug products. The HPCUS is responsible for the content, updating and publication of the HPUS. Various committees (see Structure and Functions below) assist in producing a reference based on the foundations of safety, efficacy, and standardization. This is accomplished in several ways:
- the elucidation and standardization of production methods for preparing homeopathic drug products;
- the establishment of monographs that provide uniform products when manufactured by HPUS methods;
- the assignment of these monographs into classes that carefully recognize the characteristics of the starting materials;
- the development and publication of standards for testing and quality control parameters; and
- the codification of minimum available attenuations and alcohol percentages of homeopathic tinctures.
Criteria for Eligibility
The Board of Directors of the HPCUS recognized the strong historical foundation of homeopathy in both its theory and practice. The theoretical basis of its scientific methodology has remained constant, however its format and documentation have evolved. Despite that evolution, for a medical treatment to be considered homeopathic it must reference or be reference-able to the traditionally accepted principles of homeopathy. This referencing forms a "bridge" that allows for the scientific evolution of homeopathy.
Thus, the HPCUS created the "Criteria for Eligibility of Drugs for Inclusion in the Homeopathic Pharmacopoeia of the United States" to guide the Convention’s deliberations about additions of new monographs into the HPUS. In short, the criteria require a submitted drug to be safe and effective, prepared according to the specifications of the HPUS, and that submitted documentation for the submission be in an approved format. Further, the therapeutic use of a submitted homeopathic drug needs to be supported by a) a homeopathic drug proving and clinical verification, or b) published documentation that the substance was in homeopathic use prior to 1962, or c) at least two adequately controlled double blind clinical studies or d) documented clinical experience. See the Criteria for Eligibility for more detailed information.
A medicinal preparation of biological (animal or botanical), mineral, or synthetic origin that is determined to meet the Criteria for Eligibility is designated an "Official Homeopathic Drug" after its inclusion in the HPUS.
Structure and Functions
Membership in the HPCUS is by application, which is reviewed by a subcommittee of the Board of Directors followed by review and deliberation by the whole Board. Applicants should have appropriate training and experience in one of the healing arts, biology, botany, chemistry, pharmacy, philosophy, pharmaceutical manufacture and marketing, or business management; as well as knowledge and interest in the principles of homeopathy. Due to the kind of specialized knowledge necessary to produce the HPUS, many appropriate members may come from industry. However, membership is on an individual basis and not as company representatives; further, members are expected to work for the improvement of the HPUS as a whole, without bias towards individual company goals or needs. Members participate on a voluntary basis.
The internal structure of the HPUS consists of working committees with different areas of deliberation. (More details can be found in the HPCUS Procedure Manual.)
- The Monograph Review Committee makes recommendations to the Board on the technical aspects of monographs, including nomenclature, biological classification or chemical formulae, description; method of preparation, and suggested attenuation levels for OTC/RX/External/HPN use; as well as making an initial review of references.
- The Pharmacopoeia Revision Committee makes recommendations to the Board on monographs after completing an in-depth review of the therapeutic information, to ensure compliance with the Criteria for Eligibility.
- The Clinical Documentation Committee makes recommendations to the Board regarding minimum standards of acceptable clinical information for the therapeutic use of homeopathic drug products in conjunction with the Criteria for Eligibility.
- The Toxicology and Safety Committee reviews toxicological information as the basis for recommendations to the Board regarding safe OTC and External Use attenuation levels as well as appropriate Rx and HPN attenuations.
- The Standards and Controls Committee makes recommendations to the Board for the establishment of standards and quality control tests for HPUS monographed homeopathic drug substances.
- The Council on Pharmacy makes recommendations to the Board for changes to the general information chapters and guidelines of the HPUS and other issues not related to individual monographs. Occasionally the CoP will deliberate on a specific aspect of an individual monograph as the Council’s membership includes a broader range of expertise than either the MRC or the PRC separately.
- The Board of Directors is responsible for reviewing the recommendations from the committees and approving the contents of the HPUS. The Board also has the executive and administrative responsibilities for the Convention
The HPUS is unique in the world; It is the only pharmaceutical reference officially recognized by legal statute and which is produced by a volunteer organization. And yet, for me, that fact pales in comparison to the output of the Convention, which is remarkable considering the voluntary nature of the members’ contributions. For instance, during 2019, the Convention’s committees held almost 40 meetings, of which six were all day meetings and the remainder were telecons spanning nine time zones. In total, it is calculated that more than 2,350 hours (*) of meeting and preparation time were expended by 30+ members. All of that time was voluntarily donated to ensure this reference is maintained so the information is available to the worldwide homeopathic community!
(*This does not include the hundreds of hours of webmaster work and administrative support which are also voluntarily donated.)