By Jay Bornemann MPH
Look for the initials “HPUS” after the drug names on all of your homeopathic medicines. “HPUS” means your product is prepared according to the standards of the Homeopathic Pharmacopoeia of the United States and is your assurance of a quality product.
Homeopathic medicines have been considered to be drug products under the law since the inception of the Food, Drug and Cosmetic Act, authored by Senator Royal Copeland, M.D., himself a homeopathic physician, in 1938.
Homeopathic drugs are recognized as drugs under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), 21 U.S.C. § 201 et seq. Section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), which defines the term “drug” as “articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, (i) or any supplement to any of them . . . .” (Emphasis added.)
Section 201(j) of the Act, 21 U.S.C. § 321(j), defines the term “official compendium” as the “official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary or any supplement to any of them . . . .” (Emphasis added.)
Section 501 of the Act, 21 U.S.C. § 351, relating to adulterated drugs, provides in subpart (b) that a drug is deemed to be adulterated “[i]f it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium.” That subpart also provides that:
Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia. (Emphasis added.)
Section 502 of the Act, 21 U.S.C. § 352, relating to misbranded drugs, also recognizes the Homeopathic Pharmacopoeia of the United States (or any supplement thereto) as one of three recognized “official” compendia.(ii) That section also contains two homeopathic provisos comparable to the language found in Section 501. Consequently, drugs which are recognized in the official Homeopathic Pharmacopoeia are not adulterated when they are manufactured in accordance with HPUS specifications nor are they misbranded when they are labeled in accordance with the labeling provisions of the HPUS.(iii)
On June 9, 1988, the Food and Drug Administration announced in the Federal Register, 53 Fed. Reg. 21728, the availability of Compliance Policy Guide 7132.15, “Conditions Under Which Homeopathic Drugs May be Marketed.” The Compliance Policy Guide “provides guidelines on the regulation of OTC and prescription and homeopathic drugs and describes those conditions under which homeopathic drugs may ultimately be marketed in the U.S.” The Guide reiterates the statutory declaration of the HPUS as an official compendium under Section 201(j) of the Act, and recognizes the homeopathic status of any drug which is listed in the HPUS.
So, just what is the Homeopathic Pharmacopoeia and how does it operate? Homeopathic Pharmacopoeias in one form or another have been part of the American homeopathic landscape since the nineteenth century. At the turn of the twentieth century, the American Institute of Homeopathy took up the task of publishing the HPUS, and did so without significant revision until 1979. In 1980, under the direction of Wyrth Post Baker, M.D., the AIH divested the HPUS into a separate entity, the Homeopathic Pharmacopoeia Convention of the United States (HPCUS).
The responsibility of HPCUS is defined in its Bylaws, “To accumulate pertinent information and publish and to sell the Homeopathic Pharmacopoeia of the United States and any additions or supplements thereto, to promote the art of healing according to the natural laws of cure from a strictly homeopathic standpoint: to diffuse knowledge among the laity and professionals in the health care field concerning homeopathic principles through means of publications; to research and obtain a thorough knowledge of each drug offered inclusion in the Homeopathic Pharmacopoeia of the United States as a homeopathic drug; to develop criteria for eligibility of drugs for inclusion in the Homoeopathic Pharmacopoeia of the United States; to serve as a repository for homeopathic literature and drugs; and generally to do, perform, undertake, direct, encourage and investigate all aspects and functions of any nature directed to the furtherance of homeopathic healing”. So the job is fairly complex. Yet, the primary function of HPCUS is to produce a document that allows for the standardized manufacture of homeopathic drugs in the United States; and more importantly, to define methods that assure the high quality of homeopathic medicines to professionals, consumers and government alike.
HPCUS accomplishes its task entirely with volunteers. Functionally, the Convention is divided into Administrative and Operational arms. The administrative comprises sales, marketing and financial functions. The operational involves the Monograph Review Committee and Pharmacopoeia Committee- both responsible for the addition of new substances to and review of existing substances in the HPUS and the Council on Pharmacy that involves itself with methods of manufacturing, pharmacy and labeling issues. In addition, HPCUS has a very active Standards and Controls Committee which is responsible for updating the Quality Assurance and Controls elements of the HPUS.
For a new drug to be incorporated into the HPUS, it must meet the provisions specified in the Criteria for Eligibility for Inclusion in the HPUS.
“To be eligible for inclusion in the Homeopathic Pharmacopoeia of the United States, the drug must meet criteria 1, 2, 3 and at least one of 4, 5, 6, or 7 as set forth below:
- The HPCUS has determined that the drug is safe and effective.
- The drug must be prepared according to the specifications of the General Pharmacy and relevant sections of the Homeopathic Pharmacopoeia of the United States.
- The submitted documentation must be in an approved format as set forth in the relevant sections of the Homeopathic Pharmacopoeia of the United States, and must include any data relevant to toxicity.
- 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 more information.
- 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 objective symptoms. Such use and documentation may include but are not limited to the medical literature of the following homeopathic authors: S. Hahnemann, C. Herring, T.F. Allen, H.C. Allen, J.H. Clarke and J.T. Kent.
- 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; each 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.
- 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).
It is the task of the Monograph Review Committee (MRC) evaluate a newly considered substance against these criteria. The MRC must obtain from the editor all of the technical specifications of the substance including names, composition, synonyms, synthesis, and in the case of a botanical or biological substance- identification, part used, range and habitat and collecting data. The MRC also evaluates preparatory methods as well as taking a preliminary look at the Drug Proving and evaluating how the drug will be included in the final text. MRC’s comments and questions are forwarded to the monograph sponsor, who then communicates additional information to MRC. When MRC completes its task, its comments are published for 90 days.
The information from MRC is then passed to the Pharmacopoeia Revision Committee (PRC) who review the MRC decision and focus on the drug proving. If PRC agrees with the MRC decision and finds the proving acceptable, The monograph is approved pending clinical verification.
Clinical Verification requires the sponsor to produce data to the MRC and PRC satisfaction that the drug does, in fact, have a clinical effect that is consistent with the proving. When this task is complete and the drug clinically verified, it is forwarded to the Board for final review and with their approval, accepted as an official monograph. The HPUS contains over 1200 of such monographs.
It is important to note that a subtance must meet the HPCUS minimum standards in order to be monographed and made official. In some cases, a substance may be in homeopathic clinical use, for example Petroleum, but not be official. This is because the HPCUS has been unable to determine a standard for the product, an adequate manufacturing method, or a substantiated clinical use. In the case of Petroleum, the original substance on which the proving was done is unknown. Thus the HPCUS cannot write a monograph for Petroleum with a reference standard for the manufacturing of the drug.
Issues relating to manufacturing methods, dosage forms, and general criteria for the HPUS are decided at the Council on Pharmacy (COP). COP is largely responsible for the standardization of manufacturing methodologies in the US and the harmonization of those methods with Europe. If the HPUS is a cookbook, it is the COP that the methods for cooking. Finally, the Standards and Controls Committee (S&C) is working on the standardization for drug substances themselves, along with the creation of specific quality tests for each homeopathic medicine included in the HPUS- important work, indeed. All the work of each committee is carefully reviewed and studied by the HPCUS Board of Directors. With their approval, committee changes and recommendations are enacted.
The HPCUS also serves a crucial role in advising the conditions under which a homeopathic drug should be made available on a prescription or non-prescription basis. Following carefully the FDA guidelines of self-limiting conditions, medical monitoring and diagnosis and toxicity, the HPCUS evaluates each monograph that it publishes and makes recommendations for the potency at which the substance should be sold OTC, Rx and as a homeopathic pharmaceutical necessity- that is only among manufacturers. Typically the discussion centers on the toxicity of the substance (for example, Arnica below 3X is a prescription substance due to toxicity), but in some cases, the actual use of the substance might lead to classification of Rx. HPCUS sets the minimum potencies for homeopathic drugs to be sold as OTC or Rx medications; however it has not set upper limits, e.g. Arnica Montana is tincture lowest potency on Rx, 3X lowest potency for OTC but is unrestricted in high potencies such as 1M or CM. The homeopathic industry does self-impose some retritctions on higher potencies due to safety concerns. Thus it is rare to find potencies above 30C on retail shelves.
Complicating the matter, and frankly, making some decisions controversial, is the actual licensing of homeopathic practitioners in the United States. Since homeopathic medicines are considered drugs under Federal law, and since the restriction of a homeopathic medicine to Rx status limits its sale to “Federal law prohibits dispensing without a prescription”; often times practitioners well schooled in homeopathy but without a license to practice are prevented from obtaining the substance, while fully licensed practitioners who may know nothing of homeopathy are not. This controversial twist in the regulations warrants further discussion and resolution over the years ahead. The question as to what licenses are sufficient to prescribe Rx homeopathic medicines is a matter of State law. At a minimum, most staes agree that an MD/Do or equivalent licens is sufficient. Some states recognize the ND degree and other will allow advanced practice degrees (such as advanced practice nurses) with supervision.
HPCUS also functions in a critical role of liaison with government. Often questions arise from regulators as to whether a substance is indeed homeopathic, whether it has been properly prepared or labeled, or whether its dosage from is appropriate. These questions are often answered by members of the HPCUS.
So what do the initials HPUS appended to the name of a homeopathic drug mean to the consumer? An official homeopathic drug- one which bears the notation “HPUS” on the label, has been thoroughly researched by the HPCUS. It has a drug proving or has been in long term clinical use. It has standards for method of preparation, dosage form, and quality assurance. It has bibliographic references. It is a known entity. In short, the initials “HPUS” assure the consumer, the professional and the regulator that the drug is an official homeopathic drug. Look for HPUS on the labels of all your homeopathic medicines.
The author gratefully acknowledges the assistance of Alvin J. Lorman, Esq. and HPCUS President, John A. Borneman, III in preparation of this article.
JP Borneman is President of Hyland’s, Inc, and a partner, Chairman and CEO of Standard Homeopathic Co., America’s largest manufacturer of homeopathic medicines. He is a chemist by training, with an MBA in Finance and is the fourth generation of his family to be in the business of homeopathic pharmacy. You can contact him at firstname.lastname@example.org.
- i. Since the passage of the FD&C Act, the United States Pharmacopoeia and the National Formulary have merged.
- ii. As noted, with the merger of the United States Pharmacopoeia and the National Formulary there are only two “official” compendia.
- iii. Homeopathic drugs are also covered by the Medicare-Medicaid Statute, 42 U.S.C. § 1395x(t), which defines drugs to “include only such drugs . . . as are included (or approved for inclusion) in the United States Pharmacopoeia, the National Formulary or the United States Homeopathic Pharmacopoeia.”